BD Luer-Lok, BD Eclipse 305789Recalls & reported problems
Becton, Dickinson And Company · SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB · Class 2
Quick summary
This BD Luer-Lok syringe with an Eclipse detachable needle is used for injections. The 28 adverse event reports mostly describe liquids or oily substances found inside the syringe before use, needles breaking off or snapping when the plunger was pulled back, leaking or splashing, and needles puncturing their sterile packaging. Two reports involve injuries, including needle sticks and exposure to body fluids, and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 28
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00382903057894), received between May 21, 2018 and Apr 11, 2026 — classified as 2 injuries, 26 malfunctions.
The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (6 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contamination with Chemical or Other Material6
- Leak/Splash6
- Material Protrusion/Extrusion6
- Break4
- Volume Accuracy Problem2
- Delivered as Unsterile Product1
- Device Markings/Labelling Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
- No Known Impact Or Consequence To Patient6
- No Consequences Or Impact To Patient4
- No Patient Involvement3
- Exposure to Body Fluids2
- Needle Stick/Puncture2
- No Information1
Recent adverse event reports
The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2026Break
IT WAS REPORTED BY CUSTOMER THAT THE NEEDLE BROKE OFF WHEN TRYING TO PULL BACK THE PLUNGER. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED WE HAVE A PATIENT THAT HAS BROUGHT A PRODUCT COMPLAINT FOR THE BD ECLIPSE 1 ML 27GX1/2 ITEMS. THEY STATED THAT THE NEEDLE BROKE OFF WHEN TRYING TO PULL BACK THE PLUNGER. WOULD YOU BE ABLE TO INVESTIGATE AND SEE IF YOU HAVE ANY OTHER COMPLAINTS WITH THIS ITEM. THE LOT# 5213561 AND THE EXPIRATION DATE IS 07/31/2030 OF THE ITEM IN QUESTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24852617 ↗MalfunctionJan 15, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB LEAKED. IT WAS REPORTED BY CUSTOMER THAT CLINICIANS ARE SAYING THEY ARE LEAKING. I DO NOT HAVE A SAMPLE TO TURN IN. RCC RECEIVED A COMPLAINT VIA EMAIL. CLINICIANS ARE SAYING THEY ARE LEAKING. I DO NOT HAVE A SAMPLE TO TURN IN. ITEM: 305789 QUANTITY AFFECTED: 2 EA SERIAL/LOT NUMBER: N/A PO: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21158587 ↗MalfunctionNov 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
MATERIAL: 305789, BATCH#: 4099717. IT WAS REPORTED BY THE CUSTOMER THAT THE 27G NEEDLE IN THE PACKAGE WITH THE 1ML LUER-LOCK SYRINGE IS PUNCTURING THE STERILE PACKAGING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ONE OF MY PROVIDERS REPORTED THAT A SUB ITEM THAT WAS SENT TO US RECENTLY HAS PACKAGING ISSUES. THE 27G NEEDLE IN THE PACKAGE WITH THE 1ML LUER-LOCK SYRINGE IS PUNCTURING THE STERILE PACKAGING. SO FAR, SHE HAS SEEN THESE TWO OR THREE TIMES. PRODUCT#: 305789. LOT#: 4099717.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696620 ↗MalfunctionOct 30, 2024Packaging Problem; Packaging Problem
MATERIAL # 305789; BATCH # 4099717. IT WAS REPORTED BY CUSTOMER THAT THE 27G NEEDLE IN THE PACKAGE WITH THE 1ML LUER-LOCK SYRINGE IS PUNCTURING THE STERILE PACKAGING. RCC RECEIVED A COMPLAINT VIA EMAIL. THE PRODUCT HAS PACKAGING ISSUES. THE 27G NEEDLE IN THE PACKAGE WITH THE 1ML LUER-LOCK SYRINGE IS PUNCTURING THE STERILE PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20567609 ↗MalfunctionAug 12, 2022Delivered as Unsterile Product; Delivered as Unsterile Product
IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE W/ 1 ML BD LUER-LOK¿ SYRINGE EXPERIENCED THE NEEDLE WAS NOT ATTACHED TO THE NEEDLE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BD ECLIPSE 1ML 27G X 1/2 (0.4MM X 13MM) INJECTION NEEDLE WITH LUER-LOK SYRINGE. WHEN THE NEEDLE CAP WAS REMOVED, THE NEEDLE WAS NOT ATTACHED TO THE NEEDLE PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15217235 ↗MalfunctionJun 10, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 121 BD ECLIPSE¿ NEEDLES EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME KIND OF CLEAR LIQUID WITHIN THE STERILE SYRINGE ITSELF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14658767 ↗MalfunctionJun 8, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACIST STATED CONSUMER REPORTED SEEING CLEAR LIQUID NEAR STOPPER PRIOR TO INJECTION. STATED, CONSUMER WAS CONCERNED WITH PUSHING CLEAR LIQUID INTO VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14634378 ↗MalfunctionMay 10, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ECLIPSE¿ NEEDLES EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A SUBSTANCE IN THE BARREL OF THE SYRINGE, IT IS A GREASY, OILY AND VISIBLE SUBSTANCE. ONLY A FEW BOXES ARE AFFECTED. NOT USED ON PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14349173 ↗MalfunctionFeb 28, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD ECLIPSE¿ NEEDLE 27 G X 1/2 IN. WITH DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305789 BATCH NO: 1204099 CUSTOMER CAN SEE SOME SORT OF OILY LIQUID INSIDE THE BARRELS OF THE NEEDLE/SYRING COMBO PACKAGES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13625277 ↗MalfunctionFeb 7, 2022Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES WITH DETACHABLE BD ECLIPSE¿ NEEDLE WERE MISSING THEIR SCALE MARKINGS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 ARE MISSING THE SCALE MARKINGS".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13470625 ↗MalfunctionFeb 7, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT 2 BD LUER-LOK¿ SYRINGES WITH DETACHABLE BD ECLIPSE¿ NEEDLE HAD BROWN FOREIGN MATTER INSIDE THEM. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "2 SYRINGES LOOK LIKE THERE IS SOME KIND OF BROWN SUBSTANCE ON THE INSIDE,".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13470620 ↗MalfunctionJul 20, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE WAS DIRTY INSIDE THE PACKAGING. PER COMPLAINT DETAILS RECEIVED: NOTICED THAT ONE OF THE SYRINGES WAS DIRTY, BLACK AND BROWN, HOWEVER THE PACKAGE WAS SEALED AND INTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12200540 ↗InjuryOct 5, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE SAFETY MECHANISM FAILED AND THE NURSE WAS STUCK WITH THE DIRTY NEEDLE AFTER USE. AS A RESULT, THE NURSE WENT TO THE EMERGENCY DEPARTMENT TO HAVE LABS DRAWN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE NOW HAD 2 STAFF WITH NEEDLE STICKS RELATED TO MALFUNCTIONING SAFETY SHIELDS ON THE BD ECLIPSE 27G X ½" NEEDLE (REF 305789), PLUS OTHERS WHO HAVE EXPRESSED CONCERNS BUT WERE NOT STUCK. UNFORTUNATELY, NONE OF THEM PROVIDED A LOT NUMBER OR EXPIRATION DATE, HOWEVER I BELIEVE ALL OF THE CONCERNS HAVE ARISEN IN THE LAST MONTH OR TWO, IF THAT HELPS. CONCERNS HAVE INCLUDED: AFTER THE SAFETY SHIELD WAS ENGAGED, THE NEEDLE BENT AND POKED OUT THE SIDE OF THE SHIELD. THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED. THE SAFETY SHIELD BENT & CRACKED WHEN ENGAGED, LEAVING THE NEEDLE EXPOSED. THE SHIELD FELL OFF." "I KNOW NURSES HAVE ALSO EXPRESSED THAT THE FLIP-UP SHIELD SAFETY FEATURE IS MORE CHALLENGING TO ENGAGE AND LEAVES MORE ROOM FOR A NEEDLE-S
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 10625571 ↗MalfunctionSep 27, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT 2 SYRINGES 1ML LL W/NDL ECLIPSE 27X1/2 RB WERE DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCRATCH INNER OR OUTER BARREL. CUSTOMER IS SENSITIVE TO FOREIGN MATERIAL AND ABNORMALITY OF DRUG. AFTER CONTAINING DRUG, SHE WORRIED THE SCRATCH INNER OR OUTER BARREL THAT GIVE THE BAD INFLUENCE ON DRUG EFFECTIVENESS".
Patient problems: No Patient Involvement
MAUDE report 10591300 ↗InjurySep 18, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT 2 SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB EXPERIENCED A SAFETY MECHANISM FAILURE RESULTING IN A DIRTY NEEDLE STICK INJURY. PRODUCT DEFECT OCCURRED AFTER USE. IT HAS NOT BEEN SPECIFIED WHETHER MEDICAL INTERVENTION WAS ADMINISTERED AS A RESULT OF THE DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305789, BATCH NO. UNKNOWN. I HAVE NOW HAD 2 STAFF WITH NEEDLE STICKS RELATED TO MALFUNCTIONING SAFETY SHIELDS ON THE BD ECLIPSE 27G X ½" NEEDLE, PLUS OTHERS WHO HAVE EXPRESSED CONCERNS BUT WERE NOT STUCK. UNFORTUNATELY, NONE OF THEM PROVIDED A LOT NUMBER OR EXPIRATION DATE, HOWEVER I BELIEVE ALL OF THE CONCERNS HAVE ARISEN IN THE LAST MONTH OR TWO, IF THAT HELPS. CONCERNS HAVE INCLUDED: AFTER THE SAFETY SHIELD WAS ENGAGED, THE NEEDLE BENT AND POKED OUT THE SIDE OF THE SHIELD. THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED. THE SAFETY SHIELD BENT & CRACKED WHEN ENGAGED, LEAVING THE NEEDLE EXPOSED. THE SHIELD FELL OFF. I KNOW NURSES HAVE ALSO EXPRESSED THAT THE FLIP-UP SHIELD SAFETY FEATURE IS MORE CHALLENGING TO ENGAGE AND LEAVES MORE ROOM FOR A NEE
Patient problems: Exposure to Body Fluids; Needle Stick/Puncture
MAUDE report 10554530 ↗MalfunctionSep 18, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 1ML LL W/NDL ECLIPSE 27X1/2 RB EXPERIENCED SAFETY MECHANISM FAILURE AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305789; BATCH NO. UNKNOWN. COMPLAINT 3 OF 5. I HAVE NOW HAD 2 STAFF WITH NEEDLE STICKS RELATED TO MALFUNCTIONING SAFETY SHIELDS ON THE BD ECLIPSE 27G X ½" NEEDLE (REF 305789), PLUS OTHERS WHO HAVE EXPRESSED CONCERNS, BUT WERE NOT STUCK. UNFORTUNATELY, NONE OF THEM PROVIDED A LOT NUMBER OR EXPIRATION DATE, HOWEVER, I BELIEVE ALL OF THE CONCERNS HAVE ARISEN IN THE LAST MONTH OR TWO, IF THAT HELPS. CONCERNS HAVE INCLUDED: AFTER THE SAFETY SHIELD WAS ENGAGED, THE NEEDLE BENT AND POKED OUT THE SIDE OF THE SHIELD. THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED. THE SAFETY SHIELD BENT & CRACKED WHEN ENGAGED, LEAVING THE NEEDLE EXPOSED THE SHIELD FELL OFF. I KNOW NURSES HAVE ALSO EXPRESSED THAT THE FLIP-UP SHIELD SAFETY FEATURE IS MORE CHALLENGING TO ENGAGE AND LEAVES MORE ROOM FOR A NEEDLE-STICK INJURY THAN A SAFETY DEVICE THAT ENGAGES AUTOMATICALLY FOLLOWING INJECTION (SUCH AS A POP-UP SHIELD THAT IS ACTIV
Patient problems: No Patient Involvement
MAUDE report 10554527 ↗MalfunctionSep 18, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB EXPERIENCED A SAFETY MECHANISM FAILURE WHICH WAS NOTED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305789, BATCH NO. UNKNOWN. COMPLAINT 2 OF 5. I HAVE NOW HAD 2 STAFF WITH NEEDLE STICKS RELATED TO MALFUNCTIONING SAFETY SHIELDS ON THE BD ECLIPSE 27G X ½" NEEDLE, PLUS OTHERS WHO HAVE EXPRESSED CONCERNS BUT WERE NOT STUCK. UNFORTUNATELY, NONE OF THEM PROVIDED A LOT NUMBER OR EXPIRATION DATE, HOWEVER I BELIEVE ALL OF THE CONCERNS HAVE ARISEN IN THE LAST MONTH OR TWO, IF THAT HELPS. CONCERNS HAVE INCLUDED: AFTER THE SAFETY SHIELD WAS ENGAGED, THE NEEDLE BENT AND POKED OUT THE SIDE OF THE SHIELD. THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED, THE SAFETY SHIELD BENT & CRACKED WHEN ENGAGED, LEAVING THE NEEDLE EXPOSED. THE SHIELD FELL OFF. I KNOW NURSES HAVE ALSO EXPRESSED THAT THE FLIP-UP SHIELD SAFETY FEATURE IS MORE CHALLENGING TO ENGAGE AND LEAVES MORE ROOM FOR A NEEDLE-STICK INJURY THAN A SAFETY DEVICE THAT ENGAGES AUTOMATICALLY FOLLOWING INJECTION (SUCH AS A POP-UP SHIELD THAT IS AC
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10554521 ↗MalfunctionSep 17, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT AFTER USE WITH A BD ECLIPSE¿ NEEDLE THE SAFETY MECHANISM DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (4 OF 5 COMPLAINTS) IT WAS REPORTED THAT THE SHIELD FELL OFF. - THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10551638 ↗MalfunctionSep 17, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE SAFETY SHIELD BROKE WHEN ENGAGED AFTER USE, LEAVING THE NEEDLE EXPOSED. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE NOW HAD 2 STAFF WITH NEEDLE STICKS RELATED TO MALFUNCTIONING SAFETY SHIELDS ON THE BD ECLIPSE 27G X ½" NEEDLE (REF 305789), PLUS OTHERS WHO HAVE EXPRESSED CONCERNS BUT WERE NOT STUCK. UNFORTUNATELY, NONE OF THEM PROVIDED A LOT NUMBER OR EXPIRATION DATE, HOWEVER I BELIEVE ALL OF THE CONCERNS HAVE ARISEN IN THE LAST MONTH OR TWO, IF THAT HELPS. CONCERNS HAVE INCLUDED: AFTER THE SAFETY SHIELD WAS ENGAGED, THE NEEDLE BENT AND POKED OUT THE SIDE OF THE SHIELD. THE RN HEARD THE SHIELD CLICK AND IT APPEARED TO BE ENGAGED BUT THEN IT DISENGAGED/FLIPPED DOWN LEAVING THE NEEDLE EXPOSED. THE SAFETY SHIELD BENT & CRACKED WHEN ENGAGED, LEAVING THE NEEDLE EXPOSED. THE SHIELD FELL OFF".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10551614 ↗MalfunctionAug 25, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB LEAKED ON 4 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305789 BATCH NO: 9361605. IT WAS REPORTED THAT THE TIP OF THE SYRINGE WHERE YOU ATTACH THE NEEDLE IS NOT FLAT AND LEAKS OUT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10448162 ↗MalfunctionApr 30, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PLUNGER OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE BECAME "STUCK" DURING THE PPD SKIN TEST, AND THE SOLUTION COULD NOT BE PUSHED OUT. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MEDICAL ASSISTANT WAS TRYING TO GIVE A PPD SKIN TEST. SHE WAS ABLE TO DRAW UP THE SOLUTION WITHOUT A PROBLEM. WHEN IT CAME TIME TO GIVE THE INJECTION, WHEN SHE PUSHED THE SYRINGE IN, THE SYRINGE WAS STUCK AND WOULD NOT PUSH OUT THE SOLUTION. MA TOOK OUT THE NEEDLE AND TRIED TO PUSH OUT SOLUTION WITH OUT STICKING THE EMPLOYEE AND IT WAS STILL STUCK AND UNABLE TO GET SOLUTION OUT. MA TRIED WITH ANOTHER NEEDLE AND SYRINGE FROM THE SAME BOX AND SAME PROBLEM OCCURRED AGAIN."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10015233 ↗MalfunctionApr 6, 2020Leak/Splash; Leak/Splash
IT WAS REPORTED THAT 2 SYRINGES 1ML LL W/NDL ECLIPSE 27X1/2 RB EXPERIENCED DIFFICULT PLUNGER MOVEMENT AND PRODUCT DAMAGE/DEFORMATION -DEVICE STILL OPERABLE. THE PRODUCT DEFECTS WERE NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE CAN¿T USE NORMALLY. PLUNGER REBOUNDED WHEN PULL OUT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9928951 ↗MalfunctionAug 5, 2019Volume Accuracy Problem; Volume Accuracy Problem
IT WAS REPORTED THAT A SCALE MARKING ISSUE OCCURRED BEFORE USE WITH A SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "SCALE MISSING".
Patient problems: No Patient Involvement
MAUDE report 8861640 ↗MalfunctionJun 3, 2019Leak/Splash; Short Fill; Leak/Splash; Short Fill
IT WAS REPORTED THAT THE SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB EXPERIENCED PRODUCT DAMAGE/DEFORMATION, AND SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISTORTED BARREL.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8664442 ↗MalfunctionApr 5, 2019Material Integrity Problem
IT WAS REPORTED THAT A BD¿ SYRINGE LL W/NDL ECLIPSE RB COULD NOT EJECT ALL THE SUBSTANCE OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ CUSTOMER NOTICED THE BD SYRINGE WAS NOT EXPELLING ALL THE SUBSTANCE OUT, AND IS CONCERNED. SALES REP WAS PROVIDED A SAMPLE TO RETURN TO MEDICAL MART. ¿
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8487686 ↗
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.