BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE LUER-LOK TIP

    MDR report key: 10544661 · Received September 16, 2020

    Report

    Report Number
    1213809-2020-00633
    Event Type
    Malfunction
    Date Received
    September 16, 2020
    Date of Event
    August 21, 2020
    Report Date
    September 29, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DEVICE AVAILABLE FOR EVAL?: YES. RETURNED TO MANUFACTURER ON: 9/15/2020. INVESTIGATION: ONE 3ML SYRINGE IN A FULLY SEALED BLISTER PACK CONFIRMED TO BE FROM BATCH 9042758 WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER INSIDE THE SYRINGE WAS JAMMED BETWEEN THE BOTTOM OF THE PLUNGER ROD AND THE BARREL WALL, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE 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. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER WAS MISALIGNED IN THE BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WITHIN THE CHEMOTHERAPY RECONSTITUTION DEPARTMENT OF THE PHARMACY, ON (B)(6) 2020, A SYRINGE WAS DISCOVERED BEFORE USE, WITH THE STOPPER BADLY POSITIONED FROM THE START. ANOTHER SYRINGE HAD TO BE USED."

    Additional Manufacturer Narrative · 1

    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 STOPPER WAS MISALIGNED IN THE BD PLASTIPAK¿ SYRINGE LUER-LOK¿ TIP BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "WITHIN THE CHEMOTHERAPY RECONSTITUTION DEPARTMENT OF THE PHARMACY, ON (B)(6) 2020, A SYRINGE WAS DISCOVERED BEFORE USE, WITH THE STOPPER BADLY POSITIONED FROM THE START. ANOTHER SYRINGE HAD TO BE USED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009096 BD PLASTIPAK SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 9042758 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Other