Interlink 303346Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00382903033461), received between May 8, 2018 and Feb 9, 2026 — classified as 27 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (11 reports).

2 other recalls cover devices cleared under the same FDA submission (K974363); they may or may not involve this specific model.

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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 9, 2026Expiration Date Error

  IT WAS REPORTED THAT BD SYRINGE 3ML LL W/BLUNT PLASTIC CANN LABEL CONTENT WAS INCORRECT. VERBATIM: EXPIRED PRODUCT RECEIVED. EXPIRATION DATE: 1-31-2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24290694 ↗
• MalfunctionJul 14, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/BLUNT PLASTIC CANN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #303346; LOT #5035774. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ITEM: 303346. QUANTITY AFFECTED: 8 PCS. SERIAL/LOT NUMBER: (B)(6). PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: IT WAS REPORTED BY CUSTOMER THAT THEY PULLED UP TORADOL ON A PATIENT AND NOTICED A LITTLE SLIVER OF WHAT I ASSUMED WAS A PIECE OF THE STOPPER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501126 ↗
• MalfunctionApr 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908788 ↗
• MalfunctionFeb 14, 2025Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  MATERIAL #:300912 BATCH#:4295747. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL EUROGRAPHICS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE IN THE ATTACHMENT HAS A FOREIGN SUBSTANCE ON THE TOP NEAR THE HANDLE. WE HAVE FOUND 2 OF THESE FROM THE SAME LOT# AND I HAVE 1 OF THEM IN MY POSSESSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21389694 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT THE CANNULA OF THE BD LUER-LOK¿ TIP SYRINGE WITH BLUNT PLASTIC CANNULA BROKE OFF WHEN APPLYING PRESSURE TO PUNCTURE THE MEDICATION VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT IS OVERLY DIFFICULT TO PUNCTURE THE TOP OF THE MEDICATION VIAL WITH THE BLUNT CANULA.  REVIEWING AN EVENT WHERE AN RN WAS TRYING TO APPLY ENOUGH PRESSURE AND THE CANNULA BROKE.  WHEN IT BROKE HER HAND SUDDENLY PUSHED FORWARD AND SHE CUT HERSELF WITH THE BROKEN CANULA... DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. PLEASE INCLUDE TREATMENT/INTERVENTION PROVIDED AND THE OUTCOME. RN SUSTAINED CUT TO HER HAND. DID THE EVENT INTERRUPT THE ADMINISTRATION OF ANY MEDICATION, OR CAUSE A CLINICALLY SIGNIFICANT DELAY IN MEDICATION, THAT NEGATIVELY IMPACTED THE PATIENT? IF YES, PLEASE PROVIDE DETAILS. YES. SHE HAD TO WASTE THE MEDICATION AND OBTAIN A NEW VIAL AND DIFFERENT SYRINGE. PLEASE DESCRIBE ANY ADDITIONAL, UNPLANNED MEDICAL OR SURGICAL INTERVENTION (E.G., ADDITIONAL/ALTERNATIVE MEDICATIONS, IMAGING, ETC.) REQUIRED TO AVOID PATIENT HARM, IF NOT PREVIOUSLY PROVIDED. N/A... TREATMENT WAS A BANDAID."

  Patient problems: Needle Stick/Puncture

  MAUDE report 16963116 ↗
• MalfunctionSep 21, 2022Contamination; Contamination

  IT WAS REPORTED THAT THE BD 3ML SYRINGE WITH BD BLUNT PLASTIC CANNULA EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STATED PART OF THE SYRINGE / PUNCTURE PIECES FELL INTO THE VIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460439 ↗
• MalfunctionJul 13, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT RUBBER STOPPER SHARDS FELL INTO THE VIAL AFTER IT WAS PUNCTURED WITH THE BD LUER-LOK¿ TIP SYRINGE WITH BLUNT PLASTIC CANNULA TO DRAW UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER USED LAWSON ITEM 420297 (3ML SYRINGE BD LUER-LOK TIP WITH BLUNT PLASTIC CANNULA REF (B)(4) TO DRAW UP MEDS. AFTER THE MEDICATION VIAL WAS PUNCTURED WITH THE SYRINGE, THE VIAL WAS NOTED TO HAVE RETAINED SHARDS OF THE RUBBER STOPPER FROM THE TOP OF THE VIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15009264 ↗
• MalfunctionJun 2, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT 1 BD CANNULA WITH SYRINGE INTERLINK® BLUNT TIP 3 ML HAD FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED HAVING SOME ISSUES WITH THE BLUNT PLASTIC CANNULAS IN THAT THE NURSING STAFF ARE USING THESE TO DRAW UP MEDICATIONS FROM A VIAL AND THEY ARE PUSHING PART OF THE RUBBER STOPPER INTO THE BOTTLE. EVENT DATE: UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575847 ↗
• MalfunctionDec 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE RUBBER STOPPER SHEARED AND FOREIGN MATTER WAS ASPIRATED INTO THE BD LUER-LOK¿ TIP SYRINGE WITH BLUNT PLASTIC CANNULA. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "WE HAVE HAD A MED VIAL RUBBER STOPPER SHEARING WHEN A CLINICIAN IS USING THE REF (B)(4) SYRINGE W BLUNT PLASTIC CANNULA. THIS HAS HAPPENED MULTIPLE TIMES AND THE FRAGMENT HAS BEEN ASPIRATED BACK INTO THE SYRINGE AND CAUGHT BY THE NURSE PRIOR TO INJECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122442 ↗
• MalfunctionDec 28, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN BD LUER-LOK¿ TIP WITH BLUNT PLASTIC CANNULA. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED FM. WE HAVE HAD A MED VIAL RUBBER STOPPER SHEARING WHEN A CLINICIAN IS USING THE REF 303346 SYRINGE W BLUNT PLASTIC CANNULA. THIS HAS HAPPENED MULTIPLE TIMES AND THE FRAGMENT HAS BEEN ASPIRATED BACK INTO THE SYRINGE AND CAUGHT BY THE NURSE PRIOR TO INJECTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13098575 ↗
• MalfunctionSep 3, 2021Device Contamination with Chemical or Other Material; Material Twisted/Bent; Device Contamination with Chemical or Other Material; Material Twisted/Bent

  IT WAS REPORTED THAT THE BLUNT PLASTIC CANNULA OF THE BD LUER-LOK¿ TIP SYRINGE WOULD NOT PIERCE THROUGH THE STOPPER EASILY, BENDING/DEFORMING AS A RESULT AND PUSHING THE STOPPER INTO THE MEDICATION VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BLUNT TIP DOES NOT PASS THROUGH MOST RUBBER STOPPER EASILY, YOU HAVE TO USE EXCESSIVE FORCE THAT EITHER BENDS THE TIP OR PUSHES THE STOPPER INTO THE VIAL. NOT SHARP ENOUGH TO DO THE JOB. IT IS A PT SAFETY"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422382 ↗
• MalfunctionMay 10, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303346 BATCH NO.: 1008436, 1043495, 0353219 IT WAS REPORTED THAT A PIECE OF THE SYRINGE/CANNULA BREAKS OFF AND IT IS DIFFICULT TO PUSH THE CANNULA THROUGH. PER RESPONSE EMAIL: THESE DEVICES WERE BEING USED ON THE RUBBER VIAL STOPPERS TO PULL UP THE MEDICATION, NOT THE ACTUAL CAP. THEY WERE EXTREMELY HARD TO PUSH IN AND WHEN WE DID GET THEM IN THE VIALS, THERE WERE VISIBLE FRAGMENTS IN VIAL AND PULLED UP INTO THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803513 ↗
• MalfunctionApr 14, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303346. BATCH NO: 1043495. IT WAS REPORTED THAT PLASTIC RUBBER PIECES ARE BREAKING OFF INTO THE VIAL WHEN SYRINGES ARE BEING USED. VERBATIM: CATH LAB MANAGER CAME TO PATIENT SAFETY TO NOTIFY OF THE ABOVE CONCERN: A NURSE IN THE CATH LAB STATED SHE HAS NOTICED ON ALMOST EVERY SINGLE FENTANYL THAT PLASTIC RUBBER PIECES ARE BREAKING OFF INTO THE VIAL WHEN SHE USES THE ABOVE SYRINGES. CONCERNS VOICED AS THESE MEDS ARE SOMETIMES GIVEN INTRA ARTERIAL AND CONCERNS OF DRAWING UP SMALL PLASTIC PIECES. WHEN THIS WAS VOICED WE PULLED ALL BD SYRINGES AT WASHINGTON HOSPITAL. SAFE BEING PLACED BY PATIENT SAFETY MANAGER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667827 ↗
• MalfunctionMar 30, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303346 BATCH NO: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGES WITH THE BLUNT CANNULA ARE NOT WORKING. THEY ARE DRAWING RUBBER FROM THE TOP OF THE MED VIALS INTO THE SYRINGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11593740 ↗
• MalfunctionFeb 10, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303346 BATCH NO: 9239116 AND 9239129. IT WAS REPORTED THE CANNULA IS DULL AND WHEN YOU APPLY PRESSURE IT ACTUALLY CORES THE STOPPER ON THE VIAL AND PUSHES PLASTIC INTO THE MEDICINE. VERBATIM: WE NOTICED THE ISSUE ON (B)(6) 2021. I HAVE THE LABEL AND WILL SEND THE PRODUCT. I WILL BAG EACH LOT NUMBER SEPARATELY. INJURIES OR ADVERSE EVENT: NO. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE CANNULA IS DULL AND WHEN YOU APPLY PRESSURE IT ACTUALLY CORES THE STOPPER ON THE VIAL AND PUSHES PLASTIC INTO THE MEDICINE. WE TRIED A FEW SYRINGES AND THEY ARE ALL DOING THE SAME THING. THIS IS A HUGE SAFETY CONCERN SO I NEED TO PULL ALL THE PRODUCT I HAVE ON HAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11306917 ↗
• MalfunctionNov 12, 2020Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN WAS MISSING SCALE MARKINGS ON 6 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303346, BATCH NO: 0087141. IT WAS REPORTED THAT: CUSTOMER NOTICED SCALE MARKINGS MISSING FROM BARREL OF SYRINGE.

  Patient problems: No Patient Involvement

  MAUDE report 10830722 ↗
• MalfunctionNov 7, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD 3ML SYRINGE WITH LUER-LOK¿ TIP WITH BLUNT PLASTIC CANNULAS EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303346 ; BATCH NO.: UNKNOWN. IT WAS REPORTED THAT WHEN THE NURSE PIERCED THE VIAL, A PIECE OF THE CORING FROM THE TOP OF THE VIAL WAS IN THE SYRINGE. VERBATIM: CUSTOMER CALLED IN WITH ISSUES REGARDING THE # 3033496 3ML SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9292671 ↗
• MalfunctionSep 18, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SCALE MARKING ISSUE OCCURRED BEFORE USE WITH A SYRINGE 3ML LL W/BLUNT PLASTIC CANN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "CUSTOMER OBSERVED THE 1 ML MARKING IS ACTUALLY AT THE 1.5 ML PORTION OF THE SYRINGE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9083108 ↗
• MalfunctionSep 16, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SCALE MARKING ISSUE OCCURRED BEFORE USE WITH A BD 3ML SYRINGE WITH LUER-LOK¿ TIP WITH BLUNT PLASTIC CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE 1 ML MARKING IS AT THE 1.5 ML MARKING."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9073082 ↗
• MalfunctionSep 10, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT 3 ML SYRINGE W/ BD INTERLINK¿ BLUNT PLASTIC CANNULA SCALE MARKING WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303346, BATCH NO.: UNKNOWN. IT WAS REPORTED THAT THE SCALE MARKING WAS INCORRECT MISSING THE START OF 1 SCALE MARKING. PER EMAIL: SHE STATED THAT CATALOG 303346 HAD INCORRECT SCALE MARKINGS. IT IS MISSING THE START OF 1 SCALE MARKING ON IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8981004 ↗
• MalfunctionSep 10, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT SYRINGE 3 ML LL W/BLUNT PLASTIC CAN HAD SCALE MARKING ISSUES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303346, BATCH NO: 9084976. IT WAS REPORTED THAT THE 1 ML MARKING IT IS ACTUALLY 1.5 ML PORTION OF THE SYRINGE. VERBATIM: 1 ML MARKING IT IS ACTUALLY 1.5 ML PORTION OF THE SYRINGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8980897 ↗
• MalfunctionAug 19, 2019Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT BREAKAGE OCCURRED WITH A 30 ML BD LUER-LOK¿ TIP SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PRODUCT THAT WE BEEN PURCHASING HAS BEEN DIFFICULT FOR THE PHYSICIANS IN THE ER, THE LUER-LOK TIP WITH BLUNT PLASTIC CANNULA. WE ARE WONDERING IF THERE'S ANY PRODUCT THAT MIGHT BE STRONGER ON THE TIP OF THIS ITEM. I BELIEVE THAT WHEN THEY INSERT IT THE TIP WILL BEND OR BREAK."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8905985 ↗
• MalfunctionAug 16, 2019Break; Break

  IT WAS REPORTED THAT NEEDLE IS BREAKING OFF WITH A BD SYRINGE 3ML LL W/BLUNT PLASTIC CANN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES NEEDLES ARE DULL AND WHEN NURSES ATTEMPT TO PULL MEDICATION FROM THE VIALS THE NEEDLE DAMAGES THE VIALS BECAUSE THEY DO NOT PUNCTURE. ADDITIONAL INFORMATION PROVIDED BY INITIAL REPORTER: MY ER DEPT. DID NOT SAVE ANY OF THE DAMAGED SYRINGES. I HAVE REMOVED THIS PRODUCT FROM THEIR DEPT. AND HAVE A BOX THAT I CAN SEND YOU. THE MANAGER SAYS THAT WHILE TRYING TO INSERT THE BLUNT PLASTIC END INTO THE VIAL OF MEDICINE, THE TIP STARTS TO BEND AND THEN BREAKS OFF INTO THE VIAL DAMAGING THE VIAL AND NOT ALLOWING FOR THE EXTRACTION OF THE MEDICATION. OUR MED/SURG. DEPT. IS REPORTING THAT THEY TOO ARE HAVING DIFFICULTY USING THIS SYRINGE DUE TO THE SAME PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8901481 ↗
• MalfunctionDec 11, 2018Sharp Edges

  IT WAS REPORTED THAT A BD¿ SYRINGE LL W/BLUNT PLASTIC CAN HAD A SHARP PLUNGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8152664 ↗
• MalfunctionNov 26, 2018Break

  IT WAS REPORTED WITH THE USE OF THE BD¿ BLUNT PLASTIC CANNULA THERE WAS AN ISSUE WITH PLUNGER ROD BROKEN/DAMAGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8101818 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K974363. One submission often covers many models, so check the product and lot details in each record.

• Z-1055-2015 · Dec 19, 2014 · Terminated
  BD 10 mL Syringe BD Luer-Lok Tip with Blunt Plastic Cannula, Not for Skin Injection ; Catalog #303348, BD 10 mL Syringe Luer-Lok Tip with Blunt Fill Needle 18G x 1 1/2 (1.2mm x 4
• Z-1461-06 · Jun 21, 2006 · Terminated
  BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380.