BD Ultra-Fine Insulin Syringes, 1/2mL 31G x 8MM - Kaiser 329408Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00382903294084), received between Aug 2, 2019 and Jan 13, 2022 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2022Break; Leak/Splash; Defective Component; Device Contamination with Chemical or Other Material; Break; Leak/Splash; Defective Component; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN USING THE BD ULTRA-FINE¿ II SHORT NEEDLE INSULIN SYRINGE, THE DEVICE EXPERIENCED FOREIGN MATTER ON DEVICE CANNULA / IN FLUID PATH , PLUNGER MOVEMENT DIFFICULT, LEAKAGE, FAILURE OF PRODUCT TO CONTAIN MEDICATION (I.E. CRACK, HOLE, CUT, ETC.) THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT THERE WAS A RED SUBSTANCE IN THE BARREL OF SYRINGES. SYRINGES WERE MISSING NEEDLE. ONE SYRINGE COULD NOT PULL PLUNGER OUT OF SYRINGE. ALSO REPORTED ONE SYRINGE LEAKED MEDICATION. TWO SYRINGES HAD CRACKED BARRELS. CONSUMER REPORTED ON 1 SYRINGE FOUND RED SUBSTANCES IN THE BARREL OF SYRINGES.-LOT #: 8253834D. CONSUMER REPORTED FOUND 3 WITHOUT A NEEDLE WHEN REMOVED SHIELD, SHIELD REMOVAL WENT AS NORMAL .-LOT #: 9098718 - LOT # 9343440D & LOT # 8316615B. CONSUMER REPORTED FOUND 1 SYRINGE COULD NOT PULL PLUNGER OUT OF SYRINGE.-LOT #: 6347519A. CONSUMER REPORTED FOUND 1 SYRINGE MEDICATION LEAKED OUT THE TOP OF SYRINGE WHEN IN USE/ PLUNGER AREA.-LOT #: 9042896A. CONSUMER REPORTED CALLER FOUND 1 SYRINGE NEEDLE MISSING CONSUMER REPORTED FOUND 2 SYRINGES WITH CRACKED BARRELS LOT #: 1144233C.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13256399 ↗
• MalfunctionAug 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE HUB SEPARATED FROM DEVICE AND REMAINED IN CAP WITH BD SYRINGE 0.5ML 31GA 8MM. THIS OCCURRED ON 7 SEPARATE OCCASIONS, HOWEVER, THE DATE/TIME INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN THE CONSUMER REMOVED THE ORANGE CAP FROM SEVERAL SYRINGES, THE WHOLE NEEDLE COMPONENT SEPARATES WITH IT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10371184 ↗
• MalfunctionMay 5, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 0.5ML 31GA NO INS EXPERIENCED A CANNULA THAT WAS TOO LONG. THE PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329408 BATCH NO: 8176855 CONSUMER STATED, THE NEEDLES HURT HIM WHEN HE'S TAKING HIS INJECTION BECAUSE THEY ARE TOO LONG. STATED, HE WOULD RATHER USE THE 6MM INSTEAD OF 8MM. CONSUMER STATED, HE PURCHASED 3 BOXES BUT ONLY OPENED ONE BOX. HE DOES NOT WANT TO USE ANYMORE OF THE SYRINGES BECAUSE OF THE PAIN HE EXPERIENCES WHEN TAKING INJECTION. NO INJURY TO REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10027018 ↗
• MalfunctionAug 19, 2019Break; Break

  IT WAS REPORTED THAT SEPARATION OCCURRED DURING USE WITH A SYRINGE 0.5ML 31GA NO INS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "ITEM# :329408, LOT #: 8316516. FOUND 1 SYRINGE WHEN REMOVED SHIELD, METAL NEEDLE CAME OFF SYRINGE. NO PLASTIC PART WITH IT JUST METAL. CONSUMER THINKS ITS LAYING INSIDE THE NEEDLE SHIELD. DENIED REUSING. HAS POOR VISION."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8907932 ↗
• MalfunctionAug 9, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 0.5ML 31GA NO INS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 329408 BATCH NO.: 7240986, UNKNOWN. WHEN MOVING THE PLUNGER OUTSIDE OF VIAL BEFORE DRAWING UP INSULIN, PRESSES TO THE TOP THE PLUNGER AND WHITE STUFF COMES OUT OF NEEDLE. THE PLUNGER ROD HAS A REST POSITION OF 2 UNITS. UNKNOWN OCCURRENCE DATE. FOUND THIS WHITE STUFF COMING OUT OF NEEDLE ON 6 OTHER PRIOR BOXES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8879618 ↗
• MalfunctionAug 2, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THE SYRINGE 0.5ML 31GA 8MM 10BG 500 NO INS WAS FOUND CRUSHED DURING USE, STICKING OUT FROM THE TOP OF THE SEALED BAG. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FINDING 1 PACKAGE IN BOX THAT WAS NOT SEALED AND 1 SYRINGE STICKING OUT OF THE TOP OF THAT SAME BAG, WAS CRUSHED. HE STATED, THE SYRINGE THAT WAS STICKING OUTSIDE THE BAG MAY HAVE PREVENTED THE BAG FROM BEING SEALED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8856027 ↗