Walgreens 677258Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00311917014890), received between Feb 13, 2019 and May 14, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 928851, BATCH NO. 0083457. GOOD AFTERNOON, I'VE BEEN TAKING INSULIN VIA SYRINGES FOR OVER 38 YEARS SO I'VE USED VARIOUS BRANDS OF SYRINGES. RECENTLY, MY LAST BOX CONTAINED NUMEROUS DAMAGED SYRINGES THAT WERE UNUSABLE AND HAD TO BE THROWN OUT. MOST DAMAGED ONES WERE BENT AT THE TIP AND LOOSE TO THE EXTENT THEY WERE PRACTICALLY FALLING OFF AS SOON AS I TOOK THE CAP OFF. I HAVE ONE THAT I SAVED THAT LITERALLY RIPPED THE ENTIRE NEEDLE WITH PLASTIC OFF AS SOON AS I REMOVED THE CAP. THE NEEDLES THEMSELVES ARE COMFORTABLE, WHICH IS WHY I'VE BEEN USING THEM FOR YEARS BUT THE QUALITY IS GETTING CONSISTENTLY BAD. WITH MEDICAL COSTS RISING, THIS IS SIMPLY UNACCEPTABLE TO PAY FOR SOMETHING THAT HAS TO BE THROWN OUT. ESPECIALLY WHEN INSURANCE BASES REFILLS ON A SPECIFIC NUMBER OF SYRINGES PER DAY. THEY DO NOT TAKE INTO ACCOUNT THAT THE ACTUAL PRODUCT MIGHT HAVE TO BE THROWN OUT AND WAS NOT USED DUE TO POOR QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11829463 ↗
• InjuryFeb 1, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG HAD MISSING LABEL INFORMATION DURING USE LEADING TO HYPOGLYCEMIA. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER HAD A LOW BLOOD GLUCOSE EVENT AND THE LOT# WAS MISSING FROM THE OUTSIDE OF THE BOX. VERBATIM: FROM PHONE CALL ON 2021-01-13 15:01:20: UPDATE VERBATIM CONSUMER STATED USED U500 INSULIN WITH THIS U100 SYRINGE, AS PER DOCTOR AND GOT A LOW BLOOD GLUCOSE EVENT. CONSUMER REPORTED USING THIS U100 SYRINGE WITH HER U500 LILLY INSULIN. MORNING GLUCOSE READINGS 51. INFORMED CALLER TO SPEAK WITH HER DOCTOR OR PHARMACIST. SHE STATED THEY DON'T KNOW WHAT IS THE ISSUE BUT I FEEL I'M MISSED DOSED MYSELF BECAUSE OF THIS. INFORMED CALLER THEY ARE FOR U100 INSULIN ONLY NOT U500 AND TO SEE AN ENDOCRINOLOGIST. LOT #: 9231293A FROM THE BAG- MISSING FROM THE BOX CATALOG#: 928851, DATE OF EVENT: (B)(6) 2021, SAMPLES STATUS - NO-- SHE DECLINED THE MAILING KIT AND REFUND -THEN ENDED THE CALL CONSUMER REPORTED THE LOT NUMBER FIELD ON THE BOX WAS BLANK. LOT #: UNKNOWN FROM BOX OBTAIN LOT # 9231293A, FROM THE BAG. CATALOG#: 928851 DATE OF EVENT: (B)(6) 2021 SAMPLES STATUS NO CONSUMER ENDED CALL."

  Patient problems: Hypoglycemia

  MAUDE report 11263988 ↗
• MalfunctionOct 14, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ONE BAG OF (10) SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG HAD AN EXPIRED EXPIRATION DATE BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT BAG IS EXPIRED AND DAMAGED. VERBATIM: CONSUMER REPORTED JUST PURCHASE A BAG THAT IS EXPIRED. THE BAG IS DAMAGED LOOKING TOO".

  Patient problems: Insufficient Information

  MAUDE report 10681761 ↗
• MalfunctionOct 22, 2019Material Puncture/Hole; Material Puncture/Hole

  MATERIAL NO. 928851 BATCH NO. UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE SYRINGE 0.5ML 29GA 1/2IN 10BAG 500 PL/WG THE NEEDLE WAS STICKING THROUGH SHIELD AND STUCK CONSUMER ON HIS LEFT THUMB. LITTLE BLEEDING FROM NEEDLE STICK. DID NOT SEEK MEDICAL ATTENTION. CONSUMER DID PERFORM FIRST AID AT HOME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, NEEDLE STICKING THROUGH SHIELD STUCK HIS LEFT THUMB GOT A LITTLE BLOOD FROM THE STICK. DID NOT SEEK MEDICAL. PERFORMED SOME FIRST AID AT HOME, SAYS HIS THUMB IS FINE. INCIDENT DATE: (B)(6) 2019, ITEM: 29G, 12.7, 50UNITS/928851. DID NOT HAVE BAG OR BOX TO PROVIDE ANY ADDITIONAL INFORMATION.

  Patient problems: Needle Stick/Puncture

  MAUDE report 9218058 ↗
• MalfunctionFeb 13, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE HAD 10 SYRINGES THAT HAD BENT NEEDLES AND SOME OF THE NEEDLES HAD FOREIGN MATTER ON THE NEEDLE. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8336160 ↗