BD Ultra-Fine Insulin Syringes, 1ml 31G x 8MM - Kaiser 329416Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00382903294169), received between Feb 2, 2018 and Jun 25, 2021 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE BD ULTRA FINE¿ INSULIN SYRINGE EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:329416 BATCH NO: 6236982 CONSUMER CALLED TO INQUIRE ABOUT EXPIRATION DATE ON SYRINGES, THERE IS NO EXPIRATION DATE ON THE BOX..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12064530 ↗
• MalfunctionJul 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 130 BD ULTRA FINE¿ INSULIN SYRINGE EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:329416 BATCH NO: UNKNOWN. REPORTED ON BEHALF OF CONSUMER THAT THE CONSUMER HAD APPROXIMATELY 130 INSULIN SYRINGES WITH CONDENSATION INSIDE OF THE BARREL AND POLY BAGS. STATED WHEN THE CONSUMER DRAWS UP THE INSULIN THERE IS A SMALL LINE IN THE BARREL THAT MOVES IT, BELIEVING IT IS CONDENSATION. UNABLE TO PROVIDE LOT #. DATE OF EVENT: UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10277267 ↗
• MalfunctionJun 1, 2020Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD ULTRA FINE¿ INSULIN SYRINGES EXPERIENCED FOREIGN MATTER CONTAMINATION AND DIFFICULT PLUNGER MOVEMENT. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 329416, BATCH NO: 9028862. CONSUMER REPORTED FINDING TWO SYRINGES WITH SOMETHING BLACK ON THE INSIDE OF THE BARREL. THE SYRINGES HAVE NOT BEEN USED. STATED, IT LOOKS LIKE SOMETHING MELTED ON INSIDE, BLACK IN COLOR. STATED, THE PLUNGER WAS HARD TO MOVE. DATE OF EVENT: 2020 (B)(6).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10106960 ↗
• MalfunctionAug 22, 2019Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT PLUNGER ERROR OCCURRED DURING USE WITH A SYRINGE 1.0ML 31GA NO INS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CONSUMER REPORTED HE CANNOT DRAW THE INSULIN HIS SYRINGE. HE CANNOT PULL BACK THE PLUNGER AND NOTHING COMES IN THE BARREL. HE USES THE NEW SYRINGES EACH TIME OF HIS INJECTION. HE PULLS THE RIGHT AMOUNT OF AIR IN BEFORE DRAWING SYRINGES." 4 OCCURRENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8922019 ↗
• MalfunctionNov 20, 2018Difficult to Advance

  IT WAS REPORTED THAT DURING USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THE PLUNGER ROD IS HARD TO MOVE.

  Patient problems: No Information

  MAUDE report 8089925 ↗
• MalfunctionSep 7, 2018Break; Leak/Splash

  IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE HAD A BROKEN NEEDLE WHILE DRAWING MEDICATION, AND LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7855808 ↗
• MalfunctionAug 17, 2018Component Missing

  IT WAS REPORTED THAT THE PLUNGER CAPS OF THE BD ULTRA FINE¿ INSULIN SYRINGES WERE MISSING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7795045 ↗
• MalfunctionJul 18, 2018Leak/Splash

  IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE¿ INSULIN SYRINGE THERE WAS AN ISSUE WITH LEAKAGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7699588 ↗
• MalfunctionJul 17, 2018Break; Material Puncture/Hole

  IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLE BREAKING AND HOLE IN SYRINGE. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7695836 ↗
• MalfunctionJul 11, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT BD ULTRA-FINE¿ INSULIN SYRINGE HAD "INSULIN LEAK AROUND THE NEEDLE HUB DURING INJECTION". NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679514 ↗
• MalfunctionJul 2, 2018Loose or Intermittent Connection; Material Separation; Component Missing

  IT WAS REPORTED THAT A BD ULTRA-FINE INSULIN SYRINGE "WAS MISSING THE NEEDLE. ANOTHER SYRINGE HAD THE NEEDLE INSERTED INTO THE PLASTIC END OFF- CENTER NOT CONNECTED TO THE CHAMBER. IT WAS ALSO REPORTED THAT THE SYRINGE WAS LOOSE AND WHEN PULLED OUT OF THE VIAL THE NEEDLE HAD SEPARATED FROM THE SYRINGE". NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656404 ↗
• MalfunctionJun 12, 2018Complete Blockage; Detachment Of Device Component

  IT WAS REPORTED WITH THE USE OF THE BD ULTRA-FINE INSULIN SYRINGE THERE WAS AN ISSUE WITH NEEDLE SEPARATION/CLOG. IT WAS STATED ¿THE NEEDLE DETACHED DURING INJECTION, THE CONSUMER WAS ABLE TO REMOVE ON HER OWN WITH TWEEZERS. THE CONSUMER ALSO REPORTED THAT NEEDLES FROM TWO DIFFERENT BOXES WERE CLOGGING DURING PRIMING.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7594496 ↗
• MalfunctionMay 22, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT THE NEEDLE ON A BD ULTRA-FINE¿ INSULIN SYRINGE BROKE OFF INTO THE VIAL WHEN DRAWING THE MEDICATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7534195 ↗
• MalfunctionApr 4, 2018Fluid/Blood Leak

  IT WAS REPORTED DURING USE OF THE BD ULTRA-FINE INSULIN SYRINGE THE SYRINGE IS LEAKING. THE CONSUMER REPORTED ¿WHEN DRAWING INSULIN INTO THE SYRINGE, INSULIN LEAKS AROUND NEEDLE HUB. STATED IT HAPPENED WITH FIVE SYRINGES.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396503 ↗
• MalfunctionMar 23, 2018Fluid/Blood Leak

  IT WAS REPORTED THAT WITH USE A BD¿ ULTRA-FINE INSULIN SYRINGE WAS FOUND LEAKING. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7366800 ↗
• MalfunctionFeb 2, 2018Break; Detachment Of Device Component; Entrapment of Device

  IT WAS REPORTED THAT THE NEEDLE OF A BD¿ ULTRA-FINE INSULIN SYRINGE BROKE OFF AND REMAINED IN THE MEDICATION VIAL. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7237436 ↗