BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE

    MDR report key: 14675647 · Received June 13, 2022

    Report

    Report Number
    1213809-2022-00334
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 17, 2022
    Report Date
    July 15, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 24-JUN-2022. H6: INVESTIGATION SUMMARY: THREE PHOTOS AND TEN 3ML SYRINGES IN BLISTER PACKAGES FROM BATCH 1181113 WERE RECEIVED AND EVALUATED. THREE OF THE SAMPLES WERE OBSERVED TO HAVE AN OFF-WHITE TAPE PRESENT, THERE WAS NO SEAL WHERE THE TAPE WAS PRESENT. TWO SAMPLES WERE OBSERVED TO HAVE A FOLDED OVER PIECE OF TOP WEB IN THE CORNER OF THE BLISTER PACKAGE WHICH RESULTED IN A SEAL CHANNEL. FIVE SAMPLES WERE OBSERVED TO HAVE TWO PIECES OF TOP WEB SEALED AND CLEAR PACKING TAPE WAS ALSO PRESENT ON THE BLISTER PACKAGES. THESE CONDITIONS TOGETHER RESULTED IN ALMOST A COMPLETE LACK OF A SEAL. THE OBSERVED CONDITIONS WERE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE OPEN SEAL DEFECTS IS ASSOCIATED WITH THE WITH A FAILURE TO PROPERLY CHANGE THE TOP WEB AND DEFICIENCIES RELATED TO THE WEB CHANGE PROCEDURE. IT IS LIKELY THAT THE ASSOCIATE CHANGING THE TOP WEB FAILED TO REMOVE THE OUTER LAYER THAT CONTAINED THE OFF-WHITE TAPE AND FAILED TO ENSURE THAT THE TAPE SPLICE WAS REMOVED. AS CORRECTIVE ACTIONS, UPDATED THE PROCEDURE FOR CHANGING TOP WEBS TO INCLUDE THE REQUIREMENT TO REMOVE THE OUTERMOST LAYER OF WEB PRIOR TO INTRODUCING TO THE MACHINERY AND AN QUALITY ALERT WILL BE ISSUED TO MANUFACTURING ASSOCIATES DETAILING THE DEFECT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1181113. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE THE BLISTER PACKAGE WAS OPEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿BLISTER OPEN / DOUBLE LAYER."

    Description of Event or Problem · 0

    IT WAS REPORTED BEFORE USE THE BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE THE BLISTER PACKAGE WAS OPEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿BLISTER OPEN/DOUBLE LAYER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490039 BD PLASTIPAK¿ CENTRIC LUER-LOCK HYPODERMIC THREE-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 1181113 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown