BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/INTERLINK VAC

    MDR report key: 11131273 · Received January 7, 2021

    Report

    Report Number
    1213809-2021-00004
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 9, 2020
    Report Date
    January 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903034018
    PMA / PMN Number
    K924439
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: TWO PHOTOS WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED A LOOSE 3ML SYRINGE WITH PLASTIC CANNULA ATTACHED. ONE PHOTO DISPLAYED A BLISTER PACK FROM BATCH 0150230 (P/N 303401). IT WAS OBSERVED THE PLASTIC CANNULA WAS BENT IN A 90-DEGREE ANGLE AT THE HUB CONNECTION. BASED ON THE VERBATIM, THE DEFECT DOES NOT APPEAR TO BE MANUFACTURING RELATED. PLEASE NOTE, THIS PRODUCT IS INTENDED FOR SINGLE USE TO BE USED ON PRESLITTED INTERLINK INJECTION SITES AFTER TAKING MEDICATION OUT OF A SINGLE DOSE DRUG VIALS AND IS NOT COMPATIBLE WITH CONVENTIONAL INJECTION SITES. POTENTIAL ROOT CAUSE FOR THE BENT CANNULA DEFECT MAY BE ASSOCIATED WITH CUSTOMER MISUSE. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    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."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. NEW JERSEY (NJ), USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. FDA DEVICE PROBLEM CODE: (B)(4). FDA PATIENT PROBLEM CODE: (B)(4).

    Description of Event or Problem · 1

    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."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33246 SYRINGE 3ML LL W/INTERLINK VAC HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 303401 0150230 30382903034018

    Patients

    Seq Age Sex Outcome Treatment
    1