InterlinkRecalls & reported problems across all models

We found 10 models of Interlink by Becton, Dickinson And Company in the FDA's device registry (GUDID). Together they are named in 181 adverse event reports in the FDA's MAUDE database, received between Oct 30, 2017 and Aug 3, 2026 — classified as 181 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (60 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Interlink problems

Interlink models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Interlink 303345

  Needle, hypodermic, single lumen
  83 reports
• Interlink 303346

  Needle, hypodermic, single lumen
  27 reports
• Interlink 303367

  Needle, hypodermic, single lumen
  26 reports
• Interlink 303370

  Set, administration, intravascular
  16 reports
• Interlink 303401

  Needle, hypodermic, single lumen
  12 reports
• Interlink 303348

  Needle, hypodermic, single lumen
  5 reports
• Interlink 303405

  Needle, hypodermic, single lumen
  5 reports
• Interlink 303347

  Needle, hypodermic, single lumen
  4 reports
• Interlink 303366

  Syringe, piston
  2 reports
• Interlink 303403

  Needle, hypodermic, single lumen
  1 report

Recent Interlink adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 3, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115992 ↗
• MalfunctionAug 3, 2026Fluid/Blood Leak; Manufacturing, Packaging or Shipping Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50115991 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED BY THE CUSTOMER THAT VIAL ACCESS CANNULA BREAKING IN HALF. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24567917 ↗
• MalfunctionFeb 16, 2026Contamination

  IT IS REPORTED FOREIGN MATTER. DESCRIPTION: BEDSIDE RN WAS ABOUT TO PLACE PIV IN THE ED ON A PATIENT AND WHEN OPENING, NOTICED THE BLUNT TIP SHOWED A CLEAR BROWN SUBSTANCE INSIDE THE DEVICE. RN GOT A NEW BLUNT TIP AND SYRINGE TO USE. NO HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345270 ↗
• MalfunctionFeb 9, 2026Activation, Positioning or Separation Problem

  IT IS REPORTED THE PIN DISENGAGED, AND BLUE PLASTIC PIECE REMAINS STICKING OUT OF THE VIAL. DESCRIPTION: REPORTED ISSUE: UPON DRAWING UP MEDICATIONS WITH THE NEW DISPENSING PIN (BD VIAL ACCESS CANNULA) I WAS UNABLE TO WITHDRAW ALL THE MEDICATION, OR IT LEAKED AROUND PIN. WHEN PULLING BACK TO GET THE LIQUID AT THE BOTTOM OF THE VIAL THE PIN DISENGAGED, AND BLUE PLASTIC PIECE REMAINS STICKING OUT OF THE VIAL. THIS CAUSES EITHER LESS MEDICATION TO BE DRAWN UP, OR NURSES ARE STARTING TO USE REGULAR NEEDLES TO DRAW UP MEDICATIONS. I HAD TO USE A NEEDLE TO DRAW UP THE HEPARIN THIS MORNING. THIS IS GOING TO CAUSE AN INCREASE IN NEEDLE STICK INJURIES IF WE DO NOT OBTAIN THE DISPENSING PINS WE ORIGINALLY HAD A MONTH AGO. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291495 ↗
• MalfunctionFeb 9, 2026Leak/Splash

  IT IS REPORTED LEAKAGE. DESCRIPTION: REPORTED ISSUE: UPON DRAWING UP MEDICATIONS WITH THE NEW DISPENSING PIN (BD VIAL ACCESS CANNULA) I WAS UNABLE TO WITHDRAW ALL THE MEDICATION, OR IT LEAKED AROUND PIN. WHEN PULLING BACK TO GET THE LIQUID AT THE BOTTOM OF THE VIAL THE PIN DISENGAGED, AND BLUE PLASTIC PIECE REMAINS STICKING OUT OF THE VIAL. THIS CAUSES EITHER LESS MEDICATION TO BE DRAWN UP, OR NURSES ARE STARTING TO USE REGULAR NEEDLES TO DRAW UP MEDICATIONS. I HAD TO USE A NEEDLE TO DRAW UP THE HEPARIN THIS MORNING. THIS IS GOING TO CAUSE AN INCREASE IN NEEDLE STICK INJURIES IF WE DO NOT OBTAIN THE DISPENSING PINS WE ORIGINALLY HAD A MONTH AGO. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24291489 ↗
• 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 ↗
• MalfunctionDec 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/BLUNT PLASTIC CANN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303348 LOT # 5169511 VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. PIR ATTACHED. WHEN USED TO DRAW MEDICATION, BLACK ITEMS WILL BE IN THE MEDICATION SYRINGE. ¿ PRODUCT CODE: 303348 PATIENT/HCP IMPACT: WASTING OF MEDICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23798682 ↗
• MalfunctionNov 5, 2025Break; Break

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23481189 ↗
• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/INTERLINK VAC HAD TIP BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 303405. BATCH # 5169514. VERBATIM: PHYSICIAN REPORTED THAT A BLUNT PLASTIC CANNULA BROKE AND STUCK HER WHILE ACCESSING A VIAL. SHE REPORTS THAT THIS IS THE SECOND INSTANCE OF THIS HAPPENING WITH THIS ITEM. ADDITIONAL INFORMATION PROVIDED: THIS IS THE SECOND TIME I HAVE EXPERIENCED A BREAK WITH THIS DEVICE. THE FIRST TIME WAS 1-2 YEARS AGO WHERE I WAS INJURED FROM THE PLASTIC BREAKING. AFTER THAT POINT, I HAVE ACTUALLY STOPPED USING THE PLASTIC PIECE. I TRADITIONALLY OPEN A SEPARATE BLUNT FILL NEEDLE FOR MY OWN SAFETY. THIS WEEK, I DID NOT HAVE THE BLUNT FILL NEEDLE READILY AVAILABLE AND NEEDED TO PROCEED WITH USING THE PLASTIC ONE PRE-PACKAGED WHERE I EXPERIENCED THE MALFUNCTION. FORTUNATELY, SKIN WAS NOT BROKEN THIS TIME. PREVIOUS EVENT I HAD A PUNCTURE TO MY HAND THAT REQUIRED ALTERATIONS TO SCRUBBING. I CANNOT FIND THE PHOTO THAT I SENT TO OR LEADERSHIP FROM THE PREVIOUS EVENT IN THE LAST COUPLE YEARS. THIS TIME WAS LAST MONDAY. FOR MORE DETAIL ON MY INJURY, I HAD A LACERATION THAT DID NOT REQUIRE SUTURING. I USED TOPICAL AGENTS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23481187 ↗
• 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 ↗
• MalfunctionMay 20, 2025Break; Break

  MATERIAL #303367 BATCH # 4305196 IT WAS REPORTED BY CUSTOMER THAT THE CANNULAS BREAKING/SNAPPING WHEN PREPPING MEDS. VERBATIM: CANNULAS BREAKING/SNAPPING WHEN PREPPING MEDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053396 ↗
• MalfunctionApr 25, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908788 ↗
• MalfunctionMar 28, 2025Material Integrity Problem; Material Integrity Problem

  MATERIAL: 303367 & LOT: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT DESIGN IS OFF. VERBATIM: RCC RECEIVED A COMPLAINT VIA PHONE. PRODUCT COMPLAINT: DESIGN IS OFF - 303367 CANNULA LOT UNK. CUSTOMER HAS INJURED HIMSELF. DANGEROUS, CUT HIMSELF 3X. EDGES SHARP.

  Patient problems: Insufficient Information

  MAUDE report 21719615 ↗
• MalfunctionMar 19, 2025Defective Component; Defective Component

  MATERIAL#: 303367. BATCH#: 4247046. VERBATIM: SUE, WAS ADVISED TO REACH OUT TO YOU REGARDING AN ISSUE YOU HAVE BEEN DEALING WITH AT XXXX. CENTRACARE EMS (AMBULANCE) IN XXXX HAS HAD 2 VIALS OF FENTANYL THAT WERE PUNCTURED USING THE NEW (SUB SAFETY BLUNT NEEDLE) AND WHEN DOING SO, THE VIAL RUBBER STOPS EITHER PUSHED INTO THE VIAL OR BLEW THE SEAL AND THE MEDICATION POURED OUT OF THE VIAL. THIS INCIDENT IS BEING VETTED BY OUR MANAGERS AND CLARE TO ASSURE NO FOUL PLAY, BUT IT DOESN¿T APPEAR TO BE THE CASE. 2 SPERATE MEDICS, AND IT APPEARS THAT THERE WAS NO PREVIOUS TAMPERING. 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 01-03-2025. 3. CAN YOU PLEASE PROVIDE THE NEEDLE MATERIAL AND LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? PLASTIC. LOT # 4247046.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21649325 ↗

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