Insulin Syringes, 1mL 31G x 8MM 328506Recalls & reported problems

Summary

The FDA's MAUDE database contains 104 adverse event reports that list this exact device (DI 00681131311748), received between Oct 23, 2017 and Nov 19, 2024 — classified as 3 injuries, 101 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (32 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 25 most recent of 104 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 19, 2024Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

  CONSUMER REPORTED, SOME OF THE NEEDLES "BEND". WHEN TAKING HIS INJECTION. STATED, HE IS CONCERNED, THAT THE NEEDLE MAY BREAK, DURING INJECTION. STATED, SOMETIMES THERE IS LEAKAGE, WHEN TAKING HIS INJECTION. AND HE IS NOT SURE, IF HE'S GETTING ALL OF HIS INSULIN. STATED, LATELY HIS BLOOD SUGAR HAS BEEN ANYWHERE BETWEEN 170-200, BEFORE A MEAL. STATED, HIS BLOOD SUGAR IS NORMALLY 120 MAX OR UNDER 100 BEFORE A MEAL. STATED, HE DOES RE-USE SYRINGES SOMETIMES. STATED, HE DOES ROTATE THE DIFFERENT INJECTION SITES. STATED, DID NOT SEEK MEDICAL INTERVENTION FOR BLOOD SUGAR. LOT#: 4082016, CATALOG: 328506, DATE OF EVENT: UNKNOWN. SAMPLES: YES, CL.

  Patient problems: Hyperglycemia

  MAUDE report 20727421 ↗
• MalfunctionDec 5, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED WHILE USING A BD RELION INSULIN SYRINGES 1ML 31 GAUGE, 8MM (5/16") U-100 100COUNT THE PLUNGER ROD IS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE PLUNGER ROD IS DIFFICULT TO MOVE. CONSUMER DOES NOT RE-USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18266123 ↗
• MalfunctionDec 1, 2023Crack; Crack

  IT WAS REPORTED THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS CRACKED. REPORT 1 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED "LEAKAGE" OF BARREL WHEN DRAWING UP HER INSULIN. STATED, THE BARREL WAS "CRACKED" PRIOR TO INJECTION. STATED, COULD NOT USE THE SYRINGE AND SHE WASTED INSULIN. 1 SYRINGE AFFECTED. LOT: 2157769. CATALOG: 328506. DATE OF EVENT: (STATED IT HAPPENED LAST WEEK BUT SHE CANNOT PROVIDE EXACT DATE). SAMPLE: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18251472 ↗
• MalfunctionDec 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS LEAKING. REPORT 2 OF 2. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CONSUMER REPORTED "LEAKAGE" OUR OF BARREL WHEN DRAWING UP HER INSULIN STATED, THE BARREL WAS "CRACKED" PRIOR TO INJECTION STATED, COULD NOT USE THE SYRINGE AND SHE WASTED INSULIN. 1 SYRINGE AFFECTED. LOT: 2157769. CATALOG: 328506. DATE OF EVENT: (STATED IT HAPPENED LAST WEEK BUT SHE CANNOT PROVIDE EXACT DATE). SAMPLE: YES CL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18249909 ↗
• MalfunctionOct 3, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED WHILE USING RELION¿ INSULIN SYRINGE THERE WERE SCALE MARKING ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND SEVERAL SYRINGES WITHOUT MARKING ON THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15533718 ↗
• MalfunctionJan 20, 2022Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED WHILE USING RELION¿ INSULIN SYRINGE A CRACK IN THE BARREL WAS DISCOVERED AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328506, BATCH NO. 1116704. CONSUMER REPORTED THAT THERE IS A CRACK IN THE BARREL OF THE SYRINGE NEAR THE NEEDLE HUB. BARREL OF SYRINGE LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310333 ↗
• MalfunctionDec 21, 2021Suction Failure; Suction Failure

  IT WAS REPORTED BD INSULIN SYRINGES, 1ML 31G X 8MM WERE UNABLE TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SYRINGE DOES NOT SUCTION ANYTHING WHEN PULLING BACK THE PLUNGER."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056758 ↗
• MalfunctionNov 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 RELION® INSULIN SYRINGES EXPERIENCED A DEFORMED STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING SYRIGNES WITH THE PLUNGER STOPPER MELTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787752 ↗
• MalfunctionJul 15, 2021Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THE NEEDLES BENT WHEN DRAWING THE INSULIN AND TAKING THE INJECTION. ALSO, THE SCALE MARKINGS ARE SMEARED OR MISSING. THE CONSUMER EXPERIENCED PAIN FROM THE NEEDLE FEELING ROUGH AND LEAKAGE AROUND THE HUB AND THE PLUNGER FELL OUT OF THE BARREL.   VERBATIM: CONSUMER REPORTED FOR THE PAST 10 YEARS SHE'S EXPERIENCED: NEEDLES BENDING WHEN DRAWING INSULIN. NEEDLES BENDING WHEN TAKING INJECTION. SCALE MARKINGS "SMEARED" OR "MISSING". PAIN WHEN TAKING INJECTION BECAUSE NEEDLES FEEL "ROUGH". LEAKAGE FROM AROUND THE HUB WHEN TAKING INJECTION. PLUNGER FALLING OUT OF BARREL WHEN SHE PULLS BACK. STATED, SHE WAS ENCOURAGED BY HER PHARMACIST AND DAUGHTER TO CALL IN AND REPORT ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178201 ↗
• MalfunctionJul 15, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL LEAKED AND THE PLUNGER FELL OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER THE NEEDLES BENT WHEN DRAWING THE INSULIN AND TAKING THE INJECTION. ALSO, THE SCALE MARKINGS ARE SMEARED OR MISSING. THE CONSUMER EXPERIENCED PAIN FROM THE NEEDLE FEELING ROUGH AND LEAKAGE AROUND THE HUB AND THE PLUNGER FELL OUT OF THE BARREL.   VERBATIM: CONSUMER REPORTED FOR THE PAST 10 YEARS SHE'S EXPERIENCED: NEEDLES BENDING WHEN DRAWING INSULIN. NEEDLES BENDING WHEN TAKING INJECTION. SCALE MARKINGS "SMEARED" OR "MISSING". PAIN WHEN TAKING INJECTION BECAUSE NEEDLES FEEL "ROUGH". LEAKAGE FROM AROUND THE HUB WHEN TAKING INJECTION. PLUNGER FALLING OUT OF BARREL WHEN SHE PULLS BACK. STATED, SHE WAS ENCOURAGED BY HER PHARMACIST AND DAUGHTER TO CALL IN AND REPORT ISSUES

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12178197 ↗
• MalfunctionMar 22, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE WAS UNABLE OR DIFFICULT TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE NEEDLE WILL NOT DRAW. ALSO REPORTED NEEDLE BENDS IN THE VIAL AND AT THE INJECTION SITE DURING INJECTION. LOT #: 0258067. CATALOG #: 328506. DATE OF EVENT: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11543987 ↗
• MalfunctionMar 15, 2021Break; Break

  IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL CANNULA BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328506, BATCH NO. 0904205. IT WAS REPORTED THAT NEEDLE BROKE OFF IN VIAL WHILE DRAWING UP INSULIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11490227 ↗
• MalfunctionFeb 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL HAD A MOLDING DEFECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328506 BATCH NO. 0280937. IT WAS REPORTED THAT BARRELS ARE BENT OR MELTED AND NEEDLES ARE DULL.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11341482 ↗
• MalfunctionJan 28, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT EXPIRATION DATE WAS MISSING FROM SHELF CARTON. VERBATIM: CONSUMER REPORTED MISSING THE EXPIRY DATE ON THE BOX - CONSUMER FOUND BOX IN CLOSET. UNOPENED AND UNUSED. WANTS TO USE ITEMS."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11248509 ↗
• MalfunctionJan 26, 2021Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL LEAKED, AND BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLE BROKE OFF IN THE CONSUMER'S INJECTION SITE. ALSO. INSULIN LEAKED FROM THE INJECTION SITE DURING THE INJECTION. VERBATIM: CONSUMER REPORTED THAT THE NEEDLE BROKE OFF IN HER INJECTION SITE. CONSUMER ATTEMPTED TO REMOVE THE NEEDLE WITH A TWEEZER BUT WAS UNSUCCESSFUL. U{DATE PER SNOW: CONSUMER REPORTED THAT THE NEEDLE BROKE OFF IN HER INJECTION SITE. CONSUMER ATTEMPTED TO REMOVE THE NEEDLE WITH A TWEEZER BUT WAS UNSUCCESSFUL. CONSUMER DID NOT SEEK MEDICAL ATTENTION. CONSUMER ALSO STATED THAT THE INSULIN LEAKED FROM THE INJECTION SITE DURING INJECTION. CONSUMER DOES NOT RE-USE."

  Patient problems: Foreign Body In Patient

  MAUDE report 11234207 ↗
• MalfunctionJan 18, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL HAD INCORRECT LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SYRINGES ARE USUALLY IN A WHIT BOX, BUT THIS TIME THEY ARE IN A GREEN BOX. VERBATIM: PHARMACIST REPORTED TYPICALLY THE 31G, 8MM, 1ML SYRINGES ARE IN A WHITE BOX. STATED HE HAS A BOX LABELED 31G, 8MM, 1ML SYRINGES HOWEVER THEY ARE IN A GREEN BOX WHICH IS TYPICALLY FOR THE 6MM SYRINGES. STATED HE IS UNSURE IF THE CORRECT SYRINGES ARE IN THIS BOX OR IF THE BOX IS MISLABELED. DECLINED REPLACEMENT. LOT # 0241664CAT # UNKNOWNDATE OF EVENT: 12/28/20SAMPLES: YES SENDIG MAIL KIT".

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 11189878 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THAT SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL NEEDLE BROKE OFF BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328506, BATCH NO: 0027941. VERBATIM: SPOUSE OF RELION CONSUMER REPORTED ON SYRINGE HAD THE NEEDLE BREAK OFF BEFORE THE INJECTION. STATED THE CONSUMER FILLED THE SYRINGE WITH HER INSULIN AND THEN THE END OF THE NEEDLE TIP BROKE OFF. SPOUSE STATED CONSUMER DID NOT USE THE SYRINGE AND THE SYRINGE IS STILL FILLED WITH MEDICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10907674 ↗
• MalfunctionNov 25, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT 2 RELION® INSULIN SYRINGES EXPERIENCED HUB SEPARATION FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SPOKE WITH CONSUMER TO CONFIRM PHARMACY ADDRESS. CONSUMER REPORTED, NEEDLE HUB SEPARATED WHEN REMOVING SHIELD. STATED, SHIELD WAS NOT HARD TO REMOVE. 2 SYRINGES AFFECTED. LOT: 0013346. CATALOG: 328506. DATE OF EVENT: UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10901716 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE BROKE OFF OF SYRINGE IN SITE. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES WHEN REMOVED FROM SITE NEEDLE BROKE OFF IN SITE. TWO DIFFERENT DAYS. PET OWNER ABLE TO REMOVE FROM SITE WITH HIS FINGERS. DENIED REUSE OF ITEMS. "

  Patient problems: Foreign Body In Patient

  MAUDE report 10898782 ↗
• MalfunctionNov 24, 2020Break; Break

  IT WAS REPORTED THAT A SYRINGE 1.0ML 31GA 8MM 10BAG 500 WAL BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT NEEDLE BROKE OFF OF SYRINGE IN SITE. VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES WHEN REMOVED FROM SITE NEEDLE BROKE OFF IN SITE. TWO DIFFERENT DAYS. PET OWNER ABLE TO REMOVE FROM SITE WITH HIS FINGERS. DENIED REUSE OF ITEMS. "

  Patient problems: Foreign Body In Patient

  MAUDE report 10898748 ↗
• MalfunctionOct 28, 2020Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT RELION® INSULIN SYRINGES EXPERIENCED 2 CASES OF HUB SEPARATION FROM THE DEVICE AND 1 CASE OF THE CANNULA PIERCING THROUGH THE SHIELD. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED, HE FOUND 2 SYRINGES IN A SEALED BAG WITH THE NEEDLE HUB DISPATCHED FROM THE BARREL. 2 SYRINGES AFFECTED. LOT: 0139917, CATALOG: 328506, DATE OF EVENT: UNKNOWN, STATED, HE STUCK THE PALM OF HIS HAND WHEN REMOVING A SEALED BAG FROM THE BOX BECAUSE A NEEDLE WAS STICKING THROUGH THE BAG THAT WAS STICKING THROUGH A SHIELD. DID NOT SEEK MEDICAL. STATED, SAME PRODUCT BUT LOT AND DATE OF EVENT UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751773 ↗
• MalfunctionAug 18, 2020Break; Break

  IT WAS REPORTED THAT RELION® INSULIN SYRINGE CANNULA SLIPPED OUT OF THE SYRINGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328506, BATCH NO:9259258. IT WAS REPORTED BY THE WIFE AND DAUGHTER OF THE CONSUMER THAT ONE NEEDLE FROM THIS BOX SLIPPED OUT OF THE SYRINGE DURING INJECTION, BUT THE DAUGHTER WAS ABLE TO REMOVE THE NEEDLE WITH HER FINGERS. ALSO, THE WIFE AND DAUGHTER OF THE CONSUMER REPORTED FINDING NEEDLES TO BE BENT WHEN REMOVED FROM THE INJECTION SITE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420667 ↗
• MalfunctionAug 13, 2020Break; Break

  IT WAS REPORTED THAT DURING INJECTION THE CANNULA BROKE OFF WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) IT WAS REPORTED BY THE WIFE AND DAUGHTER OF THE CONSUMER THAT ONE NEEDLE FROM THIS BOX SLIPPED OUT OF THE SYRINGE DURING INJECTION, BUT THE DAUGHTER WAS ABLE TO REMOVE THE NEEDLE WITH HER FINGERS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10405772 ↗
• MalfunctionJun 2, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT RELION® INSULIN SYRINGE WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328506 BATCH NO. 9210957. IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM BOX.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10109768 ↗
• MalfunctionApr 30, 2020Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS CUT AND STERILITY WAS COMPROMISED AS WELL AS PLUNGERS SEPARATED WITH A RELION® INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SYRINGE POLYBAGS WERE CUT. ALSO REPORTED PLUNGER CAPS LAYING IN BAGS AND SOME SYRINGE PLUNGERS WERE LAYING IN THE BAG OR EVEN MISSING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10014866 ↗