BD Ultra-Fine 328411Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 00382908411035), received between Nov 27, 2017 and Sep 29, 2026 — classified as 1 injury, 97 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (30 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Leak/Splash

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940925 ↗
• MalfunctionDec 24, 2025Material Puncture/Hole; Material Protrusion/Extrusion; Material Puncture/Hole; Material Protrusion/Extrusion

  FDA REPORT MW5178390 -FOI. EVENT DESCRIPTION- THE PATIENT HAD SQ INSULIN LANTUS ORDERED FOR ADMINISTRATION IN THE ER. THIS MEDICATION IS NOT STOCKED IN OUR PYXIS, SO THE MEDICATION WAS DRAWN UP IN PHARMACY AND GIVEN TO ME FOR ADMINISTRATION. THE NEEDLE FROM PHARMACY IS DIFFERENT FROM THE ONES WE USE IN THE ER, SO I DIDN'T NOTICE THAT THE WAS NOT A SAFETY MECHANISM (TO COVER SHARPS AFTER ADMINSTRATION) UNTIL AFTER I GAVE THE MEDICATION. AFTER THE PATIENT WAS STUCK, I RECAPPED THE NEEDLE (USING RECOMMENDED "SWEEP" METHOD), THEN PLACED TWO FINGERS ON EITHER SIDE OF THE NEEDLE CAP TO SECURE IT ON THE SYRINGE. THE NEEDLE THEN POKED THROUGH THE SIDE OF THE CAP AND INTO MY FINGER. LOT # 2108035. CATALOG# UNKNOWN - BD INSULIN SYRINGE. EXP DATE 01-APRIL 2027. DATE OF EVENT 19-OCT 2025. DATE OF MEDWATCH REPORT: 28-OCT-2025. DATE EMBECTA RECEIVED: 26-NOV-2025. SAMPLE STATUS: N/A. REPORT ATTACHED TO THIS CASE. MW5178390.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23888556 ↗
• MalfunctionNov 15, 2024Break; Defective Device; Break; Defective Device

  CONSUMER REPORTED NEEDLES BREAK DURING INJECTION. NEEDLES BEND DURING INJECTION. PLUNGER ROD BROKE WHILE INSERTING THE NEEDLE INTO THE VIAL. LOT #: 4157101. CATALOG #: 328411. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695714 ↗
• MalfunctionSep 6, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW. CONSUMER DOES NOT RE-USE. LOT #: 3285980, CATALOG #: 328411, DATE OF EVENT: UNKNOWN, SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158081 ↗
• MalfunctionJun 26, 2024Leak/Splash; Leak/Splash

  CONSUMER REPORTED FOUND 3 SYRINGES FROM THIS BOX NEEDLE HUB SEPARATED FROM THE SYRINGE AND STAYED IN THE NEEDLE SHIELD. DISCARD. DC. LOT # 2207921 FROM THE BAG. CATALOG# 328411. DATE OF EVENT JUNE 02 2024 = 1 SYRINGE OUT OF 3. DATE OF EVENT UNKNOWN = 2 SYRINGES. SAMPLE STATUS DISCARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614425 ↗
• MalfunctionJun 26, 2024Leak/Splash; Leak/Splash

  CONSUMER REPORTED FOUND 3 SYRINGES FROM THIS BOX NEEDLE HUB SEPARATED FROM THE SYRINGE AND STAYED IN THE NEEDLE SHIELD. DISCARD. DC. LOT # 2207921 FROM THE BAG. CATALOG# 328411. DATE OF EVENT JUNE 02 2024 = 1 SYRINGE OUT OF 3. DATE OF EVENT UNKNOWN = 2 SYRINGES. SAMPLE STATUS DISCARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614360 ↗
• MalfunctionApr 18, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  NEW INFORMATION AS OF 22 APRIL 2024. LOT # UPDATED FROM UNKNOWN OBTAINED DURING PHOTO INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19136302 ↗
• MalfunctionApr 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  CONSUMER REPORTED FOUND 6 NEEDLE SHIELD LAYING IN 1 SEALED SYRINGE PACKET. 5 OF THE 6 HAD THE NEEDLES STUCK IN THE SHIELDS. AND 1 SYRINGE HAD THE NEEDLE ATTACHED TO THE SYRINGE WITH JUST THE EMPTY SHIELD IN THE BAG. NO INJURY FROM THIS INCIDENT. DC LOT # 3100603 CATALOG# 328411 DATE OF EVENT (B)(6) 2024 SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19130838 ↗
• InjuryMar 21, 2024Break; Break

  CONSUMER REPORTED NEEDLE BREAK, STATED THAT ON 2-22-24 THE NEEDLE BROKE OFF IN THE INJECTION SITE. CONSUMER SAID THAT HE WENT TO THE ER AND HAD X-RAYS DONE. HE SAID A TOTAL OF 8 NEEDLES WERE SEEN ON THE X-RAYS. CONSUMER SAID HE IS GOING TO CONTACT HIS ATTORNEY. LOT #: 3233260. CATALOG #: 328411. DATE OF EVENT: 2-22-24. SAMPLES: DISCARDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18952364 ↗
• MalfunctionDec 15, 2023Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORT THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HAD 1-4 SYRINGES WITH PLUNGER STOPPER APPEARS TO BE TOO THICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING ABOUT 1-4 SYRINGES WITH PLUNGER STOPPER APPEARS TO BE TOO THICK. HARD TO MOVE PLUNGER ROD ON SYRINGE WHEN DRAWING UP INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18334215 ↗
• MalfunctionNov 20, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THEY PLUNGER ROD WAS DIFFICULT TO MOVE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING ABOUT 1-4 SYRINGES WITH PLUNGER STOPPER APPEARS TO BE TOO THICK. HARD TO MOVE PLUNGER ROD ON SYRINGE WHEN DRAWING UP INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169453 ↗
• MalfunctionNov 20, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HAD AN INSUFFICIENT CANNULA LENGTH. THE FOLLIWNG WAS RECEIVED BY THE INITIAL REPORTER: PET OWNER REPORTED, SHE FOUND ONE SYRINGE IN A PACKAGE WITH AN "INCORRECT LENGTH" STATED, IT APPEARS SHORTER THEN THE REST STATED, IT SHOULD BE A HALF INCH NEEDLE BUT IT LOOKED LIKE IT IS A 1/4 INCH NEEDLE 1 SYRINGE AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169451 ↗
• MalfunctionOct 26, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE HAD THE HUB SEPARATE FROM THE DEVICE. VERBATIM: DAUGHTER OF CONSUMER REPORTED WHEN INJECTING. INSULIN LEAKS OUT OF THE HUB, WHERE MEETING THE BARREL OF SYRINGE. RESULTING OF WASTING OF INSULIN. IT RUNS DOWN. STOMACH/SITE DAUGHTER OF CONSUMER REPORTED NEEDLE HUB SEPARATES AT TIMES FROM SYRINGE TOO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18011981 ↗
• MalfunctionOct 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS LEAKING. VERBATIM: DAUGHTER OF CONSUMER REPORTED WHEN INJECTING. INSULIN LEAKS OUT OF THE HUB, WHERE MEETING THE BARREL OF SYRINGE. RESULTING OF WASTING OF INSULIN. IT RUNS DOWN. STOMACH/SITE DAUGHTER OF CONSUMER REPORTED NEEDLE HUB SEPARATES AT TIMES FROM SYRINGE TOO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936490 ↗
• MalfunctionAug 29, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PLUNGER ROD WAS DIFFICULT TO MOVE DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643425 ↗
• MalfunctionMay 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE PLUNGER ROD WAS DIFFICULT TO MOVE DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED, ITS DIFFICULT TO PULL ON THE PLUNGER ROD WHEN DRAWING UP AND TAKING INJECTION STATED, THE PLUNGER ROD IS A LITTLE STIFF STATED, SOMETIMES HE WILL WASTE INSULIN PUSHING HARD CONSUMER ASKED IF COMPANY MANUFACTURED A DIFFERENT SYRINGE THAT HOLDS 100 UNITS AND IS EASIER TO MANAGE STATED, AS HE'S GOTTEN OLDER OVER THE YEARS, IT IS MORE DIFFICULT FOR HIM TO USE HIS HANDS BECAUSE THEY SHAKE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16921599 ↗
• MalfunctionDec 6, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE SOME NEEDLES WERE LABELED WRONG. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, SOME NEEDLES ARE SHORTER THAN 12.7.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929470 ↗
• MalfunctionDec 6, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, HE DOES NOT THINK HE'S GETTING HIS COMPLETE DOSAGE BECAUSE A "BUMP" FORMS UNDER HIS SKIN WHEN TAKING INJECTION OR LEAKS OUT. STATED, HE HAS NOT HAD ANY ISSUE WITH HIS BLOOD SUGAR SO FAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929386 ↗
• MalfunctionDec 6, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE MEDICATION COULD NOT BE INJECTED PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, HE DOES NOT THINK HE'S GETTING HIS COMPLETE DOSAGE BECAUSE A "BUMP" FORMS UNDER HIS SKIN WHEN TAKING INJECTION OR LEAKS OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15929300 ↗
• MalfunctionDec 3, 2022Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE EXPERIENCED A MIX OF PRODUCT TYPES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THAT SOME OF THE NEEDLES APPEAR TO BE A DIFFERENT LENGTH AND WILL NOT FIT INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15912105 ↗
• MalfunctionAug 10, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G PRODUCT IS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE SYRINGES WAS STICKING OUT OF THE BOX AND THE BARREL WAS BENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15199058 ↗
• MalfunctionApr 27, 2022Break; Break

  IT WAS REPORTED THAT TWO TIMES DURING USE A BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G U-100 100 COUNT, THE NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOMETIMES NEEDLE BREAKS. CALLER IS ABLE TO REMOVE THE 2 NEEDLE BREAKS IN SKIN. NO MEDICAL ATTENTION IS NEEDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14226728 ↗
• MalfunctionOct 26, 2021Expiration Date Error; Expiration Date Error

  IT WAS REPORTED BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE WAS MISSING THE EXPIRATION INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED, HE DID NOT SEE EXPIRATION DATE ON BOX".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697544 ↗
• MalfunctionOct 12, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE WAS UNABLE TO ASPIRATE, AND UNABLE TO INJECT INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I PURCHASED A BOX OF 100 OF BD ULTRA-FINE NEEDLES. THEY WILL NOT DRAW UP OR DISPERSE THE DOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12616850 ↗
• MalfunctionJul 19, 2021Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS CAPS SEPARATED FROM THE SYRINGE, EXPOSING THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE COMPLAINT IS THAT THEY REACHED IN THE BOX TO GET ANOTHER BAG (SLEEVE) OF SYRINGES AND WAS STABBED BY THE NEEDLE BECAUSE THEY LIDS WERE NOT SECURE ON THE SYRINGE IN THIS ONE SLEEVE. THEY WERE UNABLE TO USE THE PRODUCT."

  Patient problems: Needle Stick/Puncture

  MAUDE report 12194203 ↗