Relion Insulin Syringe, 1ml 6mm 328519Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00681131138345), received between Jun 28, 2018 and Jan 23, 2025 — classified as 3 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Defective Device; Defective Device

  CONSUMER REPORTED FOUND SEVERAL NEEDLE HUB ASSEMBLY NOT FULLY ATTACHED TO BARREL OF SYRINGE. WHEN INJECTING NOTICED IT WAS CROOKED AND INSULIN WOULD SHOOT OUT THE SIDE OF SYRINGE. DC. LOT # 4082020 = 1 BOX LOT # UNKNOWN =1 BOX CATALOG# 328519 DATE OF EVENT 12/28/2024 SAMPLE STATUS DISCARD DECLINED REPLACEMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225935 ↗
• MalfunctionNov 6, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT THE HAD MISSING LABEL INFORMATION. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: CONSUMER REPORTED LOT # 7178872 FROM BAG DOES NOT HAVE AN EXP DATE ON THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18077186 ↗
• MalfunctionOct 20, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD RELION INSULIN SYRINGE WAS DAMAGED. VERBATIM: IT WAS REPORTED BY THE CONSUMER REPORTED FOUND THE NEEDLES TO BE EITHER SPLIT, DULL OR ORANGE NEEDLE SHIELD PLASTIC TO BE ON THE NEEDLES. ABOUT 80 SYRINGES AND DISCARDED ALL OF THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17981481 ↗
• MalfunctionSep 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HUB SEPARATED ON THE BD¿ 0.3ML SAFETYGLIDE¿ INSULIN SYRINGE WITH 31G X 0.25IN PERMANENTLY ATTACHED NEEDLE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER ALSO REPORTED NEEDLE HUB SEPARATED INSIDE OF THE SHIELD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17685383 ↗
• MalfunctionMay 30, 2023Crack; Crack

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THERE WAS A CRACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, THE PART THAT SEATS THE NEEDLE WAS CRACKED. STATED, WAS NOT ABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019911 ↗
• MalfunctionMay 26, 2023Crack; Leak/Splash; Crack; Leak/Splash

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE THE BARREL WAS CRACKED AND INSULIN LEAKED FROM THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CONSUMER WHEN SHE DREW UP THE INSULIN AND PREPARED TO GIVE HERSELF THE INJECTION, INSULIN LEAKED FROM THE BARREL. STATED, THERE WERE "HOLES" OR "CRACKS" IN BARREL PRIOR TO INJECTION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED, WHEN SHE DREW UP THE INSULIN AND PREPARED TO GIVE HERSELF THE INJECTION, INSULIN LEAKED FROM THE BARREL. STATED, THERE WERE "HOLES" OR "CRACKS" IN BARREL PRIOR TO INJECTION. 1 SYRINGE AFFECTED, LOT: 2255901, CATALOG: 328519, DATE OF EVENT: UNKNOWN, SAMPLE: YES (B)(6). PRODUCT NAME: SYR 1.0ML 31G 6, LOT NUMBER(S) AND/OR SERIAL NUMBER(S): (B)(6), MATERIAL/CATALOG NUMBER: 328519, QUANTITY INVOLVED: 1, CONTAMINATED: NO, USED PRODUCT TO BE RETURNED FOR EVALUATION: YES, HOW MANY UNITS?: 1, IS COUNTRY EVENT OCCURRED UNKNOWN: NO, COUNTRY EVENT OCCURRED: UNITED STATES OF AMERICA, REPRESENTATIVE SAMPLES?: NO, CURRENT LOCATION OF DEVICE: END USER, REPLACEMENT OR CREDITS FOR AFFECTED DEVICES?: REPLACEMENT, BD AWARENE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17011068 ↗
• MalfunctionFeb 8, 2023Break; Break

  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: CUSTOMER STATED : SHE EMAILED ABOUT RELION NEEDLES & SYRINGES 6MMX31G. WHEN SHE USES THESE THEY GET STUCK IN HER ARM.

  Patient problems: Foreign Body In Patient

  MAUDE report 16318501 ↗
• MalfunctionApr 14, 2022Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE RELION INSULIN SYRINGE WAS UNABLE TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED SYRINGE THAT WILL NOT FILL UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14116371 ↗
• InjuryMar 30, 2022Break; Break

  IT WAS REPORTED THAT THE RELION® INSULIN SYRINGE NEEDLE BROKE OFF INTO THE CONSUMER'S STOMACH DURING THE INJECTION. THE CONSUMER VISITED THE DOCTOR, BUT THE X-RAY WAS NOT COMPLETED, AND IT WAS ADVISED TO WAIT FOR THE NEEDLE TO EVENTUALLY COME OUT ON ITS OWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FOUND A FEW SYRINGES THAT BROKE DURING INJECTION. ONE SYRINGE BROKE OFF IN STOMACH INFORMED HIS DOCTOR. DOCTOR VIEW SITE DID NOT COMPLETE XRAY JUST ADVISED TO WAIT FOR NEEDLE TO COME OUT ON ITS OWN. IT DID COME OUT ON OWN."

  Patient problems: Foreign Body In Patient

  MAUDE report 13952100 ↗
• MalfunctionJan 31, 2022Failure to Deliver; Failure to Deliver

  IT WAS REPORTED WHILE USING BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE TWO SYRINGES WERE FOUND UNABLE TO ASPIRATE THE MEDICATION. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: CONSUMER REPORTED FOUND 2 SYRINGES THAT WOULD NOT DRAW IN THE INSULIN. LOT #: 1123586. CATALOG#: 328519.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13397611 ↗
• MalfunctionOct 14, 2021Break; Break

  IT WAS REPORTED THATSYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEEDLE TIP BROKE OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE NEEDLE TIP BROKE OFF IN THE INJECTION SITE. VERBATIM: SPOUSE OF CONSUMER REPORTED THAT THE NEEDLE TIP BROKE OFF IN THE INJECTION SITE. CONSUMER WAS ABLE TO REMOVE THE NEEDLE WITH A TWEEZER, NO MEDICAL INTERVENTION, NO INJURIES. CONSUMER DOES NOT RE-USE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12637057 ↗
• MalfunctionOct 7, 2021Defective Device; Material Deformation; Defective Device; Material Deformation

  IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION WAS DAMAGED AND HAD MOLDING DEFECTS. THIS OCCURRED ON 7 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED CUSTOMER FOUND 7 BARRELS THAT ARE CRACKED AND HAVE BUBBLE LOOKING BUMPS IN THE BARRELS TOO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594653 ↗
• MalfunctionMay 6, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION HAD EXCESSIVE ADHESIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519. BATCH NO. 9350453. IT WAS REPORTED THAT IT FEELS LIKE NEEDLES ARE RIPPING THROUGH SKIN AND IS SEEING LUMPS UNDER SKIN. VERBATIM: RELION CONSUMER STATED, WHEN TAKING INJECTIONS, IT FEELS LIKE THE NEEDLE IS "RIPPING THROUGH SKIN". REPORTED, SEEING "LUMPS" UNDER SKIN. STATED, DOES NOT RE-USE AND ROTATES INJECTION SITES.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 11787663 ↗
• MalfunctionApr 23, 2021Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT A SYRINGE 1.0ML 31G 6MM S/C U-100 RELION WAS DIFFICULT TO ASPIRATE DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE WILL NOT DRAW. VERBATIM: FROM PHONE CALL ON 2021-04-12 14:36:06: CALLED CONSUMER TO OBTAIN LOT #, HE PROVIDED LOT # 9182252. CONSUMER SAID HE RECEIVED THE MAIL KIT SO I ASKED HIM TO RETURN THE SAMPLES AS SOON AS POSSIBLE AND HE SAID HE WILL. FROM PHONE CALL ON 2021-04-07 17:26:06: CALLED CONSUMER TO OBTAIN LOT #, CONSUMER STATED THAT HE DID NOT HAVE THE LOT # BUT HE WILL CALL BACK AND LEAVE A VOICEMAIL IF WE ARE CLOSED. VOICEMAIL: CONSUMER LEFT VOICEMAIL REPORTING THAT THE NEEDLE WILL NOT DRAW."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11720801 ↗
• MalfunctionApr 21, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE 1ML 31GX6MM U-100 INSULIN SYRINGE EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519 BATCH NO. 0223926. PHARMACY REPORTED IF ITEMS EXPIRED - NO EXP DATE ON BOXES. UNOPENED INFORMED OF MANUFACTURING DATES FROM LOT #. PHARMACIST THOUGHT IT WAS RECENT. DATE OF EVENT 03/25/2021.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11702295 ↗
• InjuryApr 6, 2021Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEEDLE PIECED SHIELD AND CAUSED A NEEDLE STICK INJURY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519, BATCH NO. 9210965. IT WAS REPORTED THAT NEEDLE WAS THROUGH THE WALL AND STUCK HIMSELF WITH THE NEEDLE. FINGER WAS VERY BRUISED AND WAS TESTED FOR AIDS. VERBATIM: CONSUMER REPORTED NEEDLE STUCK ON THE SIDE OF BARREL OF SYRINGE. STUCK THIS CONSUMER WHEN HE GRABBED THE PACKET. WENT TO THE DOCTOR. HIS DOCTOR COMPLETED BLOOD WORK ON HIM FOR AIDS TWICE. SAID THE FINGER LOOKED BRUISED. THIS COMPLAINT WAS RECEIVED BY EMAIL ON (B)(6) 2020 AS SPAM AND NOT PROCESSED CORRECTLY ON CS0024318. CUSTOMER STATED HE PURCHASED THE RELION SYRINGES 6MM 1CC AND ONE OF THE SYRINGES HAS A NEEDLE INBREED INSIDE THE WALL ITSELF THE INSIDE THE WALL AND IT STUCK HIM ON THE JOINT OF HIS FINGER AND HE WENT TO THE DOCTOR THIS MORNING. CUSTOMER SAID THEY RAN SOME TEST ON HIM AND HE IS WAITING FOR HIS RESULTS. INFORMED THE CUSTOMER TO PLEASE HOLD ONTO THE PRODUCT FOR POSSIBLE RETRIEVAL BY THE SUPPLIER. ISSUED $15 GIFT CARD.

  Patient problems: Needle Stick/Puncture

  MAUDE report 11619049 ↗
• MalfunctionDec 22, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT A SYRINGE 1.0ML 31G 6MM S/C U-100 RELION HAD INSUFFICIENT CANNULA LENGTH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER FEELS THE 6MM IS TOO SHORT FOR HIS THICK SKIN AND THE NEEDLE HURTS MORE THAN THE 1/2" NEEDLES. VERBATIM: CONSUMER REPORTED FEELS THE 6MM IS TOO SHORT FOR HIS THICK SKIN. GLUCOSE VALUES DID NOT INCREASE BUT FEELS THEY HURT MORE THAN THE 1/2" NEEDLES WHEN INJECTING. TAKES 50 UNITS OF INSULIN".

  Patient problems: Pain

  MAUDE report 11060721 ↗
• MalfunctionDec 21, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT IT WAS DIFFICULT TO MEASURE 5 UNITS OF INSULIN WITH RELION® INSULIN SYRINGE SCALES 1 ML MARKINGS. THIS OCCURRED WITH SYRINGES IN LOTS 0223926, 0099968, 0217457, 0006079, AND 0090421. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PET OWNER STATED HER DOG TAKES 5 UNITS OF INSULIN AND THE CURRENT SYRINGES ARE IN INCREMENTS OF 10 WHICH SHE CAN NOT USE. STATED IT IS HARD TO MEASURE 5 UNITS WITH THE 1 ML SYRINGES. STATED SHE PURCHASED 10 BOXES AND DID NOT REALIZE HOW THE SCALE MARKINGS ARE WITH THE 1ML SYRINGES. STATED HER PET WAS PREVIOUSLY USING THE 3/10 ML, 6MM SYRINGES."

  Patient problems: No Patient Involvement

  MAUDE report 11052173 ↗
• MalfunctionNov 24, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A CARTON OF SYRINGE 1.0ML 31G 6MM S/C U-100 RELION HAD MISSING LABEL INFORMATION BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THERE WAS NO EXPIRATION DATE ON SHELF CARTON. VERBATIM: RELION CONSUMER WANTED TO KNOW WHEN HER SYRINGES EXPIRE. RELION SYRINGES DO NOT HAVE AN EXPIRATION DATE ON THEM, ONLY LOT#'S BOX IS UNOPENED."

  Patient problems: No Patient Involvement

  MAUDE report 10891660 ↗
• MalfunctionNov 18, 2020Break; Break

  IT WAS REPORTED THAT ONE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THE CUSTOMER FOUND NEEDLES WITH BURRS ON THEM,, NEEDLE BENT AND NEEDLE BROKE DURING USE. VERBATIM: CONSUMER HUSBAND REPORTED FOUND NEEDLES WITH BURRS ON THEM. MOST ALL FROM FIRST BAG IN THIS BOX. CONSUMERS HUSBAND REPORTED 1 NEEDLE FROM THIS BOX BENT WHEN INJECTING CONSUMER HUSBAND REPORTED 1 NEEDLE BROKE WHEN REMOVING FROM INJECTION SITE (STOMACH) DENIED REUSE OF NEEDLES".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10860355 ↗
• MalfunctionOct 26, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF 1ML 31GX6MM U-100 INSULIN SYRINGE WALMART EXPERIENCED BROKEN THUMB PRESSES. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING THE NEEDLE TO BEND DURING INJECTION WITH LEVIMER 90 UTS CONSUMER REPORTED FINDING THE PLUNGER THUMB PRESS TO THEN SNAP AND BREAK LOT # 9350453B, CATALOG# 328519, DATE OF EVENT UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10738001 ↗
• MalfunctionOct 7, 2020Break; Break

  IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEELDE BROKE OFF IN ARM DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519 BATCH NO. 9350453. IT WAS REPORTED THAT NEEDLE BROKE OFF IN ARM DURING INJECTION. WAS REMOVED WITHOUT MEDICAL ATTENTION. VERBATIM: CONSUMER REPORTED FINDING NEEDLES BEND WHILE INJECTING OF THESE FEW SYRINGES FROM THIS BOX 2 OF THEM BROKE OFF IN ARM. HE WAS ABLE TO REMOVE ON HIS OWN. HE CLAIMS THESE WERE NEW SYRINGES. BUT HAS REUSED SYRINGES IN THE PAST FOR LONG TIMES UNDER HIS DOCTOR DIRECTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10646208 ↗
• MalfunctionOct 7, 2020Break; Break

  IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION NEELDE BROKE OFF IN ARM DURING INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328519; BATCH NO. 9350453. IT WAS REPORTED THAT NEEDLE BROKE OFF IN ARM DURING INJECTION. WAS REMOVED WITHOUT MEDICAL ATTENTION. VERBATIM: CONSUMER REPORTED FINDING NEEDLES BEND WHILE INJECTING OF THESE FEW SYRINGES FROM THIS BOX 2 OF THEM BROKE OFF IN ARM. HE WAS ABLE TO REMOVE ON HIS OWN. HE CLAIMS THESE WERE NEW SYRINGES. BUT HAS REUSED SYRINGES IN THE PAST FOR LONG TIMES UNDER HIS DOCTOR DIRECTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 10646207 ↗
• MalfunctionSep 24, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION PLUNGER ROD WAS DIFFICULT TO MOVE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 328519. BATCH NO: 9350454. IT WAS REPORTED THAT THE NEEDLES WILL NOT PENETRATE THE INSULIN VIAL OF INJECTION SITE. CONSUMER IS ALSO HAVING TO PRESS HARD ON THE PLUNGER AND IS BRUISING. EVENT DESCRIPTION PER SNOW VERBATIM STATES: RELION CONSUMER REPORTED, SOME OF THE NEEDLES WILL NOT PENETRATE THE INSULIN VIAL OR HIS INJECTION SITE. STATED, HE IS GETTING BRUISING AS A RESULT OF HAVING TO PUSH REALLY HARD ON THE SYRINGE WHEN TAKING INJECTION. STATED, DOES NOT RE-USE AND HE ROTATES DIFFERENT INJECTION SITES. STATED, HAS NOT SEEN A DOCTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10584349 ↗
• MalfunctionSep 3, 2020Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT SYRINGE 1.0ML 31G 6MM S/C U-100 RELION PLUNGER WAS MOVING ON IT'S OWN. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:328519, BATCH NO: 9231247. IT WAS REPORTED THAT THE PLUNGER MOVES ON ITS OWN BEFORE PLACED IN VIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10491967 ↗