BD SafetyGlide 305945Recalls & reported problems
Becton, Dickinson And Company · SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB · Class 2
All models of BD SafetyGlide (17)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This BD SafetyGlide 1 mL syringe has a short needle and a built-in needlestick shield. Reports mostly describe the shield failing to slide or retracting on its own, leaking medication, and grease-like contamination found on unused needles. There are 63 reports, with 16 injuries and no deaths, and needle sticks are the most common patient harm mentioned. 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
- 63
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00382903059454), received between Dec 22, 2017 and Apr 28, 2026 — classified as 16 injuries, 47 malfunctions.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Protrusion/Extrusion11
- Leak/Splash9
- Device Contamination with Chemical or Other Material7
- Fail-Safe Problem6
- Break5
- Sticking4
- Detachment Of Device Component3
- Device Operates Differently Than Expected3
Patient problems
- No Known Impact Or Consequence To Patient21
- No Clinical Signs, Symptoms or Conditions17
- Needle Stick/Puncture15
- No Consequences Or Impact To Patient7
- Exposure to Body Fluids3
- Chest Tightness/Pressure1
- Foreign Body In Patient1
- Injury1
Recent adverse event reports
The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 28, 2026Material Perforation
IT WAS REPORTED THAT BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB NEEDLE WENT THROUGH THE SHIELD. COMPLAINT VIA EMAIL. I'LL ENTER A X EVENT BUT HERE ARE THE ACCOMPANYING PICS. IT MAY BE DIFFICULT TO SEE BUT THIS IS AN UNUSED NEEDLE AND OUT OF THE PACKAGE IT ALREADY HAS THE NEEDLE POKING THROUGH THE SAFETY- IT CAME THAT WAY. THIS WOULD MEAN IT IS HARDER TO ENGAGE THE SAFETY AND A POTENTIAL RISK TO THE STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019074 ↗MalfunctionFeb 27, 2026Leak/Splash
IT WAS REPORTED THAT BD SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB WAS NOTED TO HAVE LEAKAGE. RCC RECEIVED A COMPLAINT VIA EMAIL. WHEN APPLYING A TB TEST WITH THE TUBERCULIN SYRINGE, THE SOLUTION WAS LEAKING FROM THE HUB OF THE NEEDLE AND NOT THE LUMEN. CUSTOMER RESPONSE ON (B)(6) 2026. I SUPPOSE I CANNOT CONFIRM THE EXACT LOT# IF THAT IS NOT AN ACTIVE NUMBER. THE TWO I HAVE IN CLINIC ARE: 4310099D1 EXP: 11/20/2029. 3227561J1 EXP: 08/31/2028. WHICH APPEARS TO BE A COMBINATION OF BOTH LOTS. MAYBE THE EXPIRATION CAN HELP IDENTIFY WHICH ONE BASED ON WHAT I SENT YOU EARLIER? I AM NOT FAMILIAR WITH THE MATERIAL NUMBER, IS IT THIS? REF: 305945. THE ONLY NEGATIVE OUTCOME IS THAT I HAD TO POKE THE PATIENT 2X BUT SHE WAS UNDERSTANDING WITH IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24474690 ↗MalfunctionApr 21, 2025Leak/Splash; Leak/Splash
IMDRF CODES MUST BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21877226 ↗MalfunctionAug 22, 2024Retraction Problem; Retraction Problem
IMDRF CODES MUST BE UPDATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20044783 ↗MalfunctionAug 5, 2024
BD SAFETYGLIDE 1ML SYRINGE 27G X 1/2 (0.4MM X13MM) WAS USED TO ADMINISTER HEPARIN SUBCUTANEOUSLY, AS ORDERED. WHEN GOING TO INJECT PATIENT WHILE USING THIS SYRINGE, PRIMARY REGISTERED NURSE (RN) NOTED THE NEEDLE RETRACTED INTO THE SYRINGE SOMEHOW UPON NEEDLE CONTACT WITH PATIENT. SYRINGE/NEEDLE IMMEDIATELY REMOVED FROM PATIENT. NEEDLE TIP EXAMINED, AND NO SIGNS OF ANYTHING BREAKING OFF. PATIENT WITHOUT ANY INJURY BUT HAD TO BE POKED AGAIN WITH A NEW SYRINGE/NEEDLE IN ORDER TO RECEIVE MEDICATION. REF: 305945, (B)(4), EXPIRATION: 2029-01-31, LOT NUMBER: 4005009B.
Patient problems: Chest Tightness/Pressure; No Clinical Signs, Symptoms or Conditions
MAUDE report 19905446 ↗MalfunctionFeb 8, 2024Defective Component; Defective Component
IT WAS REPORTED THAT THE BD SAFETYGLIDE SAFETY MECHANISM BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ENTIRE SAFETY DEVICE SLIDE UP AND OFF THE SYRINGE WHEN THE NURSE DEPLOYED IT. I WANTED TO BRING IT TO YOUR ATTENTION IN CASE THERE HAS BEEN ANY OTHER INCIDENTS. STAFF MAY NOT REPORT IT IF IT OCCURS WHEN THERE IS NO NEGATIVE CONSEQUENCE. THE RN DISCARDED IT BUT SHOWED THE CHARGE NURSE PRIOR TO DOING SO. CHARGE NURSE VERIFIED HER ACCOUNT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18671080 ↗MalfunctionJan 15, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE BD SAFETYGLIDE SYRINGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY OPENED UP ONE NEEDLE TODAY (B)(6) 2023 AND THERE WAS A GREASELIKE SUBSTANCE ON THE NEEDLE ITSELF. IT WAS UNDER THE CAP ON THE NEEDLE. THEY FOUND IT WITH ONE NEEDLE SO FAR. THEY DID DOCUMENT BY TAKING PHOTOGRAPHS AND WILL SEND IN." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 23: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO 2. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? NO 3. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? PHOTOS ARE AVAILABLE THE PHYSICAL NEEDLE WAS PLACED IN A SHARPS CONTAINER WITH OTHER NEEDLES. 4. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO HEALTH CONSEQUENCES OR IMPACT, ISSUE WITH NEEDLE WAS NOTICED BEFORE TB TEST PLACED AND A NEW NEEDLE FROM A DIFFERENT LOT NUMBER WAS USED. 5. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? NEW NEEDLE FROM A DIFFERENT LOT NUMBER WAS USED. 6. PATIENT STATUS? FINE 7. ANY PICTURE OF THIS COMPLAINT YES AND THEY ARE ATTACHED. 8. PLEASE EXPLAIN ELABORATE ISSUE? ON OPENING O
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18515181 ↗MalfunctionOct 12, 2023Leak/Splash; Loose or Intermittent Connection; Leak/Splash; Loose or Intermittent Connection
IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ TUBERCULIN SYRINGE SEPARATES CAUSING LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE/NEEDLE THAT WAS NOT CONNECTED CORRECTLY. UPON INJECTING INTO THE VIAL, THE MEDICATION LEAKED FROM THE SYRINGE AND RENDERED THE PRODUCT UNUSABLE. OUR PSR FOR XIAFLEX ON THE CALL INITIALLY WAS HANDLING THE REPLACEMENT PROCEDURE. COUNSELED HER TO LET THE STAFF KNOW TO INITIALLY TIGHTEN THE SYRINGE AFTER OPENING JUST IN CASE THEY COME SLIGHTLY LOOSE FROM THE MANUFACTURER AS THAT CAN HAPPEN BUT IT COULD HAVE BEEN A DEFECTIVE DEVICE AS WELL. UNKNOWN IF PATIENT MISSED A DOSE OR EXPERIENCED AN ADVERSE EVENT AS A RESULT OF DEFECTIVE SYRINGE. UNKNOWN IF DEFECTIVE SYRINGE IS AVAILABLE FOR RETURN. NO FURTHER INFORMATION.
Patient problems: Insufficient Information
MAUDE report 17924960 ↗MalfunctionJun 28, 2023Leak/Splash; Leak/Splash
IT WAS REPORTED THAT DURING USE WITH BD SAFETYGLIDE¿ TUBERCULIN SYRINGE THE NEEDLE LEAKED WHILE GIVING AN INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NEEDLE LEAKS AFTER GIVING AN INJECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17222303 ↗MalfunctionApr 13, 2023Material Separation; Material Separation
MAT# 305945. LOT# 2221003A1. IT WAS REPORTED BY THE CUSTOMER THAT AFTER INJECTION, THE REGISTERED NURSE WENT TO ENGAGE THE NEEDLE CAP COVER WITH HER INDEX FINGER AND AS SHE PUSHED THE COVER DEVICE FELL OFF (COMPLETE DISCONNECTION FROM SYRINGE). NO HARM TO STAFF OR PATIENT. (B)(4). LOT# 2221003A1 (NOT ABLE TO FIND IN SAP) EVENT TITLE: NO EVENT TITLE PROVIDED DESCRIBE THE EVENT OR PROBLEM: AFTER INJECTION, THE REGISTERED NURSE WENT TO ENGAGE THE NEEDLE CAP COVER WITH HER INDEX FINGER AND AS SHE PUSHED THE COVER DEVICE FELL OFF (COMPLETE DISCONNECTION FROM SYRINGE). NO HARM TO STAFF OR PATIENT. WHAT PROBLEM DID THE USER HAVE (CHECK ALL THAT APPLY) :DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO; ADDITIONAL INFO RECEIVED ON 31MAR2023 WERE YOU ABLE TO CORRECT THE ISSUE USING ANOTHER NEEDLE? BASED ON INFORMATION KNOWN AT THIS TIME, THE MEDICATION HAD ALREADY BEEN ADMINISTERED AND THE PROTECTIVE CAP FELL OFF WHEN THE NURSE ATTEMPTED TO ENGAGE THE DEVICE. NO OTHER DEVICE WAS NEEDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16740582 ↗MalfunctionSep 26, 2022Failure to Deliver; Failure to Deliver
IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ TUBERCULIN SYRINGE NEEDLE WAS BLOCKED DURING THE VACCINE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CALLER STATES THEY ARE LOOKING FOR SYRINGE NEEDLE COMBINATION (27G NEEDLE) TO ACCOMMODATE THE FDA GUIDELINES FOR THE MONKEYPOX VACCINE. THEY ARE CURRENTLY USING PRODUCT CODE: 305945 AND 305946 AND ARE UNABLE TO GET THE FULL 0.1ML (5TH DOSE) FROM THE VIAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15489474 ↗InjuryMay 4, 2022Break; Break
IT WAS REPORTED THAT BD TUBERCULIN SYRINGE WITH NEEDLE SAFETYGLIDE¿ BROKE OFF IN THE PATIENT AND THE HEALTH CARE PROVIDER WAS STUCK WITH THE DIRTY NEEDLE. IT WAS REPORTED NEEDLE BROKE OFF. EVENT DATE: (B)(6) 2022. AWARENESS DATE: 7-APR-2022. COMPLAINT: THE SYRINGE BROKE OFF IN THE PATIENT, THE NEEDLE STUCK THE RN.
Patient problems: Foreign Body In Patient; Needle Stick/Puncture
MAUDE report 14274927 ↗MalfunctionApr 28, 2022Fail-Safe Problem; Fail-Safe Problem
IT WAS REPORTED THAT (B)(4) TUBERCULIN SYRINGE WITH NEEDLE SAFETYGLIDE¿ 1 ML 27 GAUGE 1/2 INCH HAD A SHIELD THAT WAS DIFFICULT TO REMOVE AND HAD A NEEDLE THAT WAS DIFFICULT TO SEPARATE FROM THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT IS COMPLICATED TO REMOVE NEEDLE COVER AND NOT POSSIBLE TO FIGURE OUT HOW TO GET NEEDLE READY TO WORK. I HAD FEW COLLEAGUES AROUND IN ATTEMPTS TO REMOVE SAFETY COMPONENT FROM NEEDLE AND WE COULD NOT. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14242636 ↗MalfunctionApr 15, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED WHILE USING BD 1-ML TUBERCULIN SYRINGE WITH 27-G X 1/2-IN PERMANENTLY ATTACHED NEEDLE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS A PROBLEM WITH A SYRINGE. 1ML SYRINGE CONTAINED A CLEAR LIQUID INSIDE THE SYRINGE, AND A BLACK SPECK INSIDE ONE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14121330 ↗MalfunctionOct 14, 2021Failure to Cut; Failure to Cut
IT WAS REPORTED THAT SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SAFETY MECHANISM SEEMS FLIMSY AND BARELY COVERS THE NEEDLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12629440 ↗MalfunctionAug 18, 2021Retraction Problem; Retraction Problem
IT WAS REPORTED THAT THE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB EXPERIENCED A SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: NO PATIENT INVOLVEMENT, SAFETY MEASURES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12340418 ↗MalfunctionAug 18, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THIS IS NOT THE SPECIFIC LOT NUMBER, ALL THE SYRINGES RELEASE DUST. VERBATIM: SYRINGE PACKAGE RELEASES SMALL DUST PARTICLE FROM OPENING THE SYRINGE PACKAGE. THIS IS AN ISSUE BECAUSE STERILE IV ROOM REQUIRES NO DUST TO BE DELIVERED THROUGH ANY ITEMS UPON OPENING IN STERILE IV HOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12339201 ↗MalfunctionJul 30, 2021Leak/Splash; Leak/Splash
IT WAS REPORTED SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB BROKE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE RETAINED THE BROKEN SYRINGE. ACCORDING TO WEST ONE, THIS IS THE ONLY OCCURRENCE WITH THE ITEM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12256307 ↗MalfunctionJul 22, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BD¿ SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE¿ SAFETY NEEDLE LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING AT THE BLUE SECTION."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12215616 ↗InjuryMar 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE BD¿ SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE¿ SAFETY NEEDLE CAUSED A DIRTY NEEDLE STICK TO THE NURSE WHEN THEIR THUMB SLIPPED PAST THE SAFETY. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 5 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "INCREASED NUMBER OF NURSE NEEDLE STICKS THAT SEEM TO HAVE BEEN WITH THE SAFETY GLIDE SYRINGES."
Patient problems: Needle Stick/Puncture
MAUDE report 11466986 ↗MalfunctionOct 8, 2020Break; Leak/Splash; Break; Leak/Splash
IT WAS REPORTED THAT SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB WAS DAMAGED, BUT STILL OPERABLE THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED A POSSIBLE LOSS OF FLUID DURING INJECTING. VERBATIM: 2020-09-17: CALLED CONSUMER TO ASSIST WITH VOICEMAIL THAT WAS RECEIVED HOWEVER, CONSUMER DID NOT ANSWER. ATTEMPTED TO LEAVE VM AND HALFWAY THROUGH VM MESSAGE MACHINE DISCONNECTED. WILL FOLLOW UP AGAIN. EMAIL RECEIVED: 2020-09-15 16:15:4.1 HELLO, RECEIVED VOICEMAIL TODAY FROM CUSTOMER WHO WANTS TO KNOW IF WE OFFER A SYRINGE WHERE THE PISTON GOES ALL THE WAY INTO THE HUB OF THE SYRINGE TO MINIMIZE THE LOSS OF FLUID. SO IT SOUNDS LIKE HE MAY BE EXPERIENCING SOME LOSS OF FLUID DURING INJECTING. HE SAID MATERIAL # 305945. PHONE NUMBER XXX-XXX-XXXX".
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10653892 ↗MalfunctionOct 2, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE SAFETY MECHANISM ON THE BD¿ SYRINGE WITH PERMANENTLY ATTACHED BD SAFETYGLIDE¿ SAFETY NEEDLE FAILED AND "FLEW OFF" WHEN ENGAGED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THE SAFETY WAS ENGAGED ON THE BD SAFETYGLIDE 1ML SYRINGE, THE SAFETY FLEW OFF AND DIDN'T CAP NEEDLE. VERY BIG POTENTIAL FOR NEEDLE STICK. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? NUMBING FOR IV. WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED."
Patient problems: No Patient Involvement
MAUDE report 10624094 ↗MalfunctionSep 22, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver
IT WAS REPORTED THAT SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB PLUNGER MOVEMENT WAS DIFFICULT. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305945; BATCH NO.: 9345879. IT WAS REPORTED THAT: PLUNGER MOVEMENT DIFFICULT. EVENT DESCRIPTION PER EMAIL STATES: "RN VERIFIED RIGHT DOSE,ROUTE, TIME, AND PATIENT FOR MORNING ENOXAPARIN DOSE WITH SECOND RN. RN THEN INJECTED THE NEEDLE INTO PATIENT'S SUBCUTANEOUS TISSUE, BUT WHEN THE PLUNGER WAS PRESSED, THE MEDICATION WOULD NOT DELIVER (PLUNGER WOULD NOT ADVANCE) RN IMMEDIATELY REMOVED NEEDLE FROM PATIENT, DREW BACK AIR BUT WAS STILL UNABLE TO ADVANCE THE PLUNGER, NO MATTER HOW MUCH FORCE WAS USED. DOSE WAS GIVEN TO PHARMACY FOR INVESTIGATION AND PHARMACY MADE NEW DOSE. FAULTY SYRINGE NEEDLES/PLUNGERS HAVE BEEN VERBALLY REPORTED WITH OTHER PATIENT'S ENOXAPARIN DOSES AND RN REPORTING TO BRING ATTENTION TO PHARMACY. PATIENT WAS UPSET THAT SHE HAD TO BE POKED A SECOND TIME FOR SECOND ENOXAPARIN ADMINISTRATION DOSE." THE MEDWATCH REPORTED WAS RECEIVED IN FRANKLIN LAKES ON 04-JUN-2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE RCC UNTIL 09/17/2020.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10570899 ↗InjuryJul 23, 2020Leak/Splash; Retraction Problem; Leak/Splash; Retraction Problem
IT WAS REPORTED THAT THE SYRINGE SFTYGLD 1ML W/NDL 27X1/2 RB EXPERIENCED A BROKEN SAFETY MECHANISM, BLOOD EXPOSURE-SPLASH, AND A POST USE DIRTY NEEDLE STICK INJURY. PRODUCT DEFECTS WERE NOTED AFTER USE. IT HAS NOT BEEN SPECIFIED WHETHER ANY MEDICAL INTERVENTION WAS RECEIVED AS A RESULT OF THE NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305945. BATCH NO: 6131957. SAFETY GLIDE NEEDLE COVER DEPLOYED AFTER TB SKIN TEST PERFORMED. ABLE TO UNLOCK SAFETYGLIDE COVER WHICH SLID BACK AND RESULTED IN A NEEDLESTICK INJURY.
Patient problems: Exposure to Body Fluids
MAUDE report 10312869 ↗MalfunctionJun 23, 2020Break
WHEN THE SAFETY WAS ENGAGED ON THE BD SAFETYGLIDE 1ML SYRINGE, THE SAFETY FLEW OFF AND DIDN'T CAP NEEDLE. VERY BIG POTENTIAL FOR NEEDLE STICK.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10183668 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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