BD Ultra-Fine 328468Recalls & reported problems

Summary

The FDA's MAUDE database contains 323 adverse event reports that list this exact device (DI 00382908468039), received between Nov 2, 2017 and Sep 25, 2026 — classified as 6 injuries, 317 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (127 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 323 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Leak/Splash; Failure to Deliver; Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897600 ↗
• InjurySep 25, 2026Leak/Splash; Failure to Deliver; Defective Device

  Consumer reported, the plunger rod was difficult to move on two of the syringes. Stated, he had to push really hard to get the insulin to come out and that caused him pain in the injection site. Stated, 2 more syringes leaked around the part where the needle sits because it was bent.Stated, the needle was not bent. The part that holds the needle was bent. So that's four syringes in total he had a problem with. Lot: 4065022,Catalog: 328468,Date of Event: Unknown,Samples: Yes, CL.This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken one additional complaint record was created for Plunger Difficult to Move, one complaint record for Needle Pain, one complaint record for Leakage, and one complaint record for Hub Damaged/Bent. With these actions completed, this Intake record is now consistent with applicable procedures (b)(4), and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information be

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897288 ↗
• MalfunctionSep 25, 2026Leak/Splash; Failure to Deliver; Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896848 ↗
• MalfunctionSep 25, 2026Leak/Splash; Failure to Deliver; Defective Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50896500 ↗
• MalfunctionApr 25, 2025Volume Accuracy Problem; Volume Accuracy Problem

  CONSUMER REPORTED FINDING 4 BOXES WITH THE SAME LOT NUMBER, MARKING OFF ON THE BARREL OF THE SYRINGES. FIRST CALLED IN 1 SYRINGE ON CASE # 00023345. CONSUMER SENT IN SEVERAL SYRINGES WITH THIS CASE MAIL KIT. DC. LOT # 4156009, CATALOG# 328468, DATE OF EVENT UNKNOWN, SAMPLE STATUS AWAITING SAMPLE (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21909935 ↗
• MalfunctionMar 28, 2025Volume Accuracy Problem; Volume Accuracy Problem

  CONSUMER REPORTED FINDING 1 SYRINGE FROM THIS BOX WITH THE ZERO MARKER ON THE BARREL TO BE AT 1 UNIT AND NOT ZERO. LOT # 4156008, CATALOG# 328468, DATE OF EVENT UNKNOWN, SAMPLE STATUS AWAITING SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21726000 ↗
• MalfunctionNov 15, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED FOUND 1 SYRINGE 10.22.2024 WITHOUT MARKING ON THE BARREL. DC CONSUMER REPORTED FOUND 1 SYRINGE UNKNOWN EVENT DATE, WHEN YOU MOVED THE PLUNGER TO PLACE AIR INTO THE SYRINGE, THE PLUNGER WOULD NOT DRAW IN THE AIR. DISCARDED THIS SAMPLE. DC. LOT #4065022, CATALOG# 328468, SAMPLE STATUS AWAITING SAMPLE 1 SYRINGE WITHOUT MARKING ON THE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695390 ↗
• MalfunctionNov 15, 2024Volume Accuracy Problem; Volume Accuracy Problem

  CONSUMER REPORTED FOUND 1 SYRINGE 10.22.2024 WITHOUT MARKING ON THE BARREL. CONSUMER REPORTED FOUND 1 SYRINGE UNKNOWN EVENT DATE, WHEN YOU MOVED THE PLUNGER TO PLACE AIR INTO THE SYRINGE, THE PLUNGER WOULD NOT DRAW IN THE AIR. DISCARDED THIS SAMPLE. LOT #4065022. CATALOG# 328468. SAMPLE STATUS AWAITING SAMPLE 1 SYRINGE WITHOUT MARKING ON THE BARREL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695353 ↗
• MalfunctionSep 20, 2024Leak/Splash; Leak/Splash

  CONSUMER REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE. CONSUMER DOES NOT RE-USE. LOT #: 3289933, CATALOG #: 328468, DATE OF EVENT: UNKNOWN, SAMPLES AVAILABLE: DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268569 ↗
• MalfunctionAug 23, 2024Leak/Splash; Leak/Splash

  VOICE MESSAGE CONSUMER REPORTED FOUND 1 SYRINGE NEEDLE HUB STUCK WITHIN THE NEEDLE SHIELD. (B)(4). LOT # 1256483. CATALOG# 328468. DATE OF EVENT JULY 28, 2024. SAMPLE STATUS DISCARD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20053783 ↗
• MalfunctionJul 3, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED HAVING DIFFICULTIES MOVING THE PLUNGER DURING DRAWING OF AIR AND INSULIN. DC LOT # 3352052 CATALOG# 328468 DATE OF EVENT UNKNOWN SAMPLE STATUS AWAITING SAMPLES - ONES HE FEELS FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669381 ↗
• MalfunctionMay 24, 2024Material Puncture/Hole; Material Puncture/Hole

  CONSUMER REPORTED HARD TO OPEN THE BAG OF SYRINGES. CONSUMER REPORTED IN THIS BAG FOUND 2 SYRINGES THE NEEDLE WAS THRU THE NEEDLE SHIELD, AND STUCK HER FINGER. CALLER IS FINE NO MEDICAL ATTENTION WAS NEEDED. DC LOT # 3352052 CATALOG# 328468 DATE OF EVENT 05.05.2024 SAMPLE STATUS AWAITING SAMPLE

  Patient problems: Needle Stick/Puncture

  MAUDE report 19396053 ↗
• MalfunctionApr 17, 2024Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver

  PET OWNER REPORTED -I GET YOUR BD SYRINGES (1/2 ML) MONTHLY FOR MY 2 CATS. HAVE BEEN FOR THE PAST YEAR NOW, BUT THE LAST FEW MONTHS I HAVE SYRINGES THAT JUST DON'T WORK. THERE IS NO SUCTION WHEN TRYING TO GET THE INSULIN OUT OF PEN. IS THERE AN ISSUE WITH THESE. THEY ARE NOT CHEAP AND I AM GETTING RID OF AT LEAST 2 IN EACH BAG. PLEASE ANY INFO WOULD BE GREAT. IF THEY HAVE TO WRITE FOR DIFFERENT NEEDLES I NEED TO LET THEM KNOW. ITEM # 328468.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127575 ↗
• MalfunctionMar 29, 2024Volume Accuracy Problem; Volume Accuracy Problem

  CONSUMER REPORTED THAT THERE IS NO SCALE MARKINGS ON ONE OF HIS SYRINGES. HE STATED THAT THE SYRINGE IS COMPLETELY CLEAR. LOT #: 3205873. CATALOG #: 328468. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19007046 ↗
• MalfunctionMar 5, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED PLUNGER ROD WAS STIFF AND DIFFICULT TO MOVE PRIOR TO DRAWING INSULIN. STATED, COULD NOT USE SYRINGE 1 SYRINGE AFFECTED LOT: 9259098 CATALOG: 328468 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18836854 ↗
• MalfunctionFeb 12, 2024Failure to Deliver; Failure to Deliver

  CONSUMER REPORTED, SOME OF HER NEEDLES ARE NOT DRAWING THE MEDICATION. STATED, SHE FOUND A "PLUNGER ONLY" IN HER PACKAGE BUT ALL OF THE OTHER PIECES THAT COMPLETE A SYRINGE WERE MISSING, (BARREL, SHIELD, NEEDLE, CAP). LOT: 3233304. CATALOG: 328468. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18685057 ↗
• MalfunctionJan 16, 2024Crack; Crack

  CONSUMER REPORTED BARREL HAS A CRACK IN IT. DC. LOT # 3114051. CATALOG# 328468. DATE OF EVENT 12/20/2023. SAMPLE STATUS AWAITING SAMPLE. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18521829 ↗
• MalfunctionNov 28, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PLUNGER ON THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS DIFFICULT TO MOVE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: PLEASE SEE THE ATTACHED DOCUMENT FOR SOMES CUSTOMER RETURNS THAT CAME BACK AS DEFECTIVE I NEED TO RETURN FOR CREDIT. CAN YOU PLEASE ISSUE RA'S? PLEASE LET ME KNOW IF YOU NEED ANYTHING ELSE. PLUNGER HARD TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18220504 ↗
• MalfunctionOct 4, 2023Break; Break

  IT WAS REPORTED THAT THE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE BREAKS OFF. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED, NEEDLES BEND AND SOMETIMES BREAK WHEN TAKING INJECTION. STATED, IF A NEEDLE BREAKS OFF IN HER SKIN, SHE IS ABLE TO REMOVE IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17873239 ↗
• MalfunctionSep 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT WHILE USING THE BD ULTRA-FINE¿ INSULIN SYRINGE THE PLUNGER WAS DIFFICULT TO MOVE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17794919 ↗
• MalfunctionJun 27, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT PRIOR TO USE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE HUB WAS DISCOVERED TO BE BROKEN. 1ST OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED, THE PART THAT HOLDS THE NEEDLE IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213514 ↗
• MalfunctionJun 27, 2023Break; Break

  IT WAS REPORTED THAT PRIOR TO USE WITH BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE CANNULA BROKE OFF. 2ND OF 2 EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THAT THERE WERE MISSING NEEDLES BEFORE INJECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17213513 ↗
• MalfunctionMay 30, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT THE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE, THE NEEDLE HUB SEPARATES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE NEEDLE SHIELD DIFFICULT TO REMOVE. NEEDLE BENT WHILE TRYING TO REMOVE THE SHIELD. ALSO REPORTED NEEDLE HUB SEPARATED."

  Patient problems: Insufficient Information

  MAUDE report 17027032 ↗
• MalfunctionMay 12, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16925102 ↗
• MalfunctionMay 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE CANNULA BROKE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THAT NEEDLE SEPARATED FROM THE HUB FROM ONE SYRINGE AND AN ADDITIONAL SYRINGE WAS MISSING THE THUMB PRESS,UNBLE TO READ THE LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16907093 ↗