BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 10759763 · Received October 29, 2020

    Report

    Report Number
    1213809-2020-00767
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    October 9, 2020
    Report Date
    November 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-10-28. INVESTIGATION SUMMARY: ONE PHOTO AND ONE 3ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 0183088 (P/N 309657) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN THE PHOTO AND PHYSICAL SAMPLE, THERE WAS NO VISIBLE PRINT ON THE SYRINGE BARREL, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING 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 LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HAD NO SCALE MARKINGS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "OPENED BD 3ML SYRINGE TO ADMINISTER MEDICATION AND SYRINGE HAD NO MARKINGS FOR MEASUREMENT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON DATE VIA MEDWATCH # 4900240000-2020-8101. 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 LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP HAD NO SCALE MARKINGS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "OPENED BD 3ML SYRINGE TO ADMINISTER MEDICATION AND SYRINGE HAD NO MARKINGS FOR MEASUREMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220073 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0183088 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1