BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 11159473 · Received January 13, 2021

    Report

    Report Number
    1213809-2021-00012
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 2, 2020
    Report Date
    March 15, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/1/2021. H.6. INVESTIGATION: TWO PHOTOS AND ONE PHYSICAL SAMPLE OF A 5ML EUROGRAPHIC SYRINGE WITH TIP CAP AND OPENED BLISTER PACK CONFIRMED TO BE FROM BATCH #9070842 (P/N 309649) WERE RECEIVED AND EVALUATED. THE SYRINGE WAS OBSERVED TO HAVE A LENGTHWISE CRACK EXTENDING FROM THE 4ML GRAD LINE TO JUST ABOVE THE 2ML GRAD OUTSIDE OF THE PRINT AREA. SUPERFICIAL EXTERIOR SCRAPES WERE ALSO OBSERVED ON AND BELOW THE LETTERS "AS" OF THE "PLASTIPAK" PRINT. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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 THE BD SYRINGE LUER-LOK¿ TIP HAD A CRACK IN IT THAT WAS VISIBLE WHEN THE PLUNGER WAS PULLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "THE SYRINGE WAS USED IN OUR CYTOSTATICS PRODUCTION. IT WAS DRAWN UP ONLY WITH WATER FOR INJECTION, BUT A CRACK WAS FOUND ON THE TIP OF A SYRINGE. THE CRACK IS VISUALLY VISIBLE ONLY WHEN THE PLUNGER IS PULLED, AS THE PLUNGER COVERS THE CRACK."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP HAD A CRACK IN IT THAT WAS VISIBLE WHEN THE PLUNGER WAS PULLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(4) TO ENGLISH: "THE SYRINGE WAS USED IN OUR CYTOSTATICS PRODUCTION. IT WAS DRAWN UP ONLY WITH WATER FOR INJECTION, BUT A CRACK WAS FOUND ON THE TIP OF A SYRINGE. THE CRACK IS VISUALLY VISIBLE ONLY WHEN THE PLUNGER IS PULLED, AS THE PLUNGER COVERS THE CRACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58236 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 9070842 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1