Interlink 303401Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00382903034017), received between Jul 8, 2019 and Oct 25, 2024 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2024Defective Component; Defective Component

  MATERIAL#: 303401, BATCH#: 4155698. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/INTERLINK VAC BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: QUALITY ISSUE WITH 3ML SYRINGE. HOLE IN SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20539866 ↗
• MalfunctionJul 8, 2024Volume Accuracy Problem; Volume Accuracy Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19690950 ↗
• MalfunctionMay 15, 2024Volume Accuracy Problem; Volume Accuracy Problem

  MATERIALS#: 303401 .BATCH#: 3348875. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/INTERLINK VAC HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "3ML BD LUER-LOK TIP WITH VIAL ACCESS CANNULA SYRINGE WITHOUT ML MARKINGS. CAN¿T MEASURE AN AMOUNT OF MEDICATION INSIDE WITHOUT MARKINGS" VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE RECEIVED A REPORT FROM OUR SAINT RAPHAEL¿S CAMPUS CLINICIANS CONCERNING AN EVENT THEY HAVE EXPERIENCED WHILE USING A 3ML BD LUER-LOK TIP WITH VIAL ACCESS CANNULA SYRINGE (BD303401). THE LOT NUMBER IS 3348875. THE EVENT DATE IS (B)(6) 2024. NO HARM TO THE PATIENT HAS BEEN REPORTED. THE SAMPLE IS SEQUESTERED TO CONDUCT AN ANALYSIS TO DETERMINE THE ROOT CAUSE OF THE FAILURE. PLEASE LET ME KNOW THE NEXT STEP. WE ARE WILLING TO SEND THE SAMPLE. PLEASE HAVE AN RMA AND MAILER LABEL SENT TO MY ATTENTION. THE COMPLAINT IS DESCRIBED: S; 3ML BD LUER-LOK TIP WITH VIAL ACCESS CANNULA SYRINGE WITHOUT ML MARKINGS. B: CAN¿T MEASURE AN AMOUNT OF MEDICATION INSIDE WITHOUT MARKINGS . A: LOT # 3348875. R: ITEM SEQUESTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326092 ↗
• MalfunctionDec 20, 2021Break; Break

  IT WAS REPORTED THAT THE NEEDLE OF THE BD INTERLINK¿ LUER-LOK TIP SYRINGE WITH VIAL ACCESS CANNULA BECAME STUCK IN THE VIAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATED THAT THERE IS A BLUE TIP CANNULA INSIDE THE SYRINGE THAT STAYS STUCK IN VIAL."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13048058 ↗
• MalfunctionNov 2, 2021Break; Break

  IT WAS REPORTED THAT THE 3ML BD LL SYRINGE EXPERIENCED A NEEDLE THAT BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE WENT COMPLETELY PERPENDICULAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12736637 ↗
• MalfunctionJun 10, 2021Break; Break

  IT WAS REPORTED THAT THE BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA EXPERIENCED A NEEDLE THAT BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303401 BATCH NO.: 1069247. THE ISSUE WITH THE BLUE CAPPED CANNULA OCCURED 5/9. THE PRODUCT WAS THE 3ML BD LUER LOK TIP WITH VIAL ACCESS CANNULA. AS THE EMPLOYEE WAS ATTEMPTING TO PUT THE ACCESS CANNULA INTO THE VIAL, SHE MET RESISTANCE. SHE TRIED TO PUSH HARDER AND THE ACCESS CANNULA BROKE OFF. HER HAND SLIPPED AND SHE LACERATED A FINGER ON THE OTHER HAND. SHE HAD TO CLEANSE AND COVER THE CUT. BUT NO FURTHER MEDICAL INTERVENTIONS WAS NEEDED. IT STILL WAS HEALING WHEN I SAW THE INJURY A FEW DAYS LATER.

  Patient problems: Laceration(s)

  MAUDE report 11980710 ↗
• MalfunctionJun 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA WAS DAMAGED AND THE INTERLINK DISCONNECTED FROM THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED BY THE HEALTH PROFESSIONAL THAT THE NEEDLES ARE DIFFICULT TO PUSH THROUGH MEDICATION VIALS, DOES NOT ASPIRATE ALL THE MEDICATION, AND DOES NOT ALLOW FOR MULTIPLE DOSES. IT WAS ALSO REPORTED THAT THE NEEDLE BENT AND CAUSED A NEEDLE STICK INJURY TO THE USER'S HAND. "

  Patient problems: Needle Stick/Puncture

  MAUDE report 11951684 ↗
• MalfunctionJan 7, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYRINGE 3ML LL W/INTERLINK VAC WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303401 BATCH NO.: 0150230 IT WAS REPORTED THAT THE STAFF IS EXPERIENCING QUALITY ISSUES WITH THE SYRINGE. PER EMAIL: "I'VE HAD MANY STAFF REPORTING QUALITY ISSUES, AND THE STAFF ARE NOT HAPPY WITH THE PRODUCT OVERALL. THE PREVIOUS ITEM ALLOWED NURSING TO INSERT AND REMOVE SEVERAL TIMES (INTO THE SAME SYRINGE). THIS PRODUCT DOES NOT ALLOW FOR THIS."

  Patient problems: No Patient Involvement

  MAUDE report 11131273 ↗
• MalfunctionOct 8, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A BROKEN PLUNGER WAS FOUND AT AN UNSPECIFIED TIME WITH A BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "A DAMAGED 3ML SYRINGE. "CROOKED PLUNGER" .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9168595 ↗
• MalfunctionOct 1, 2019Volume Accuracy Problem; Volume Accuracy Problem

  IT HAS BEEN REPORTED THAT ONE BD 3ML SYRINGE WITH LUER-LOK TIP WITH VIAL ACCESS CANNULA HAS BEEN FOUND EXPERIENCING SCALE MARKING ISSUES BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT "THE SYRINGES HAVE NO MARKINGS ON THEM". CUSTOMER TEXT: THE SYRINGES HAVE NO MARKINGS ON THEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9141740 ↗
• MalfunctionAug 9, 2019Failure to Align

  DURING AN INJECTION,THE BEVEL OF THE SYRINGE WAS NOT LEVEL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8878749 ↗
• MalfunctionJul 8, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD 3ML SYRINGE W/ LUER-LOK¿ TIP WITH VIAL ACCESS CANNULA PLUNGER ROD WAS DAMAGED AND LEAKED. THIS WAS DISCOVERED DURING USE. NO DATE/TIME OR PATIENT INFORMATION WAS GIVEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303401 BATCH NO: 9060931. IT WAS REPORTED THAT PLUNGER IS NOT FLUSH INSIDE THE BARREL, CAUSING THE SYRINGE TO LEAK. PER CUSTOMER EMAIL: THERE SEEMS TO BE AN ISSUE WITH THE BD 3ML SYRINGE REF # 303401 (P/S 27638). PUT IN A SAFETY NET COMPLAINING THAT THE MEDICATION IS LEAKING OUT OF THE SYRINGE ON A FEW OCCASIONS. AFTER PHYSICALLY LOOKING AT THE SYRINGE SHE HANDED ME, I NOTICED THAT THE PLUNGER IS NOT FLUSH INSIDE THE BARREL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8769117 ↗