BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 9879339 · Received March 25, 2020

    Report

    Report Number
    1213809-2020-00209
    Event Type
    Malfunction
    Date Received
    March 25, 2020
    Date of Event
    March 5, 2020
    Report Date
    April 22, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVAL YES, RETURNED TO MANUFACTURER ON: 2020-04-15. H.6. INVESTIGATION SUMMARY: TWO PHOTOS AND ONE 1ML SYRINGE IN AN OPENED BLISTER PACK FROM BATCH 9210930 (P/N 309628) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER INSIDE THE SYRINGE WAS JAMMED BETWEEN THE BARREL WALL AND THE PLUNGER ROD, WHICH WAS REJECTABLE PER PRODUCT SPEFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9210930 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP RUBBER STOPPER WAS FOUND DEFORMED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A PHARMACY AND IT HAPPENED HERE, BEFORE USE. THE PACKAGE IS OPEN AND THE SYRINGE UNUSED. THE RUBBER STOPPER LOCATED ON THE PLUNGER AT THE BOTTOM OF THE SYRINGE IS DEFORMED. IT HAS HAPPENED ONLY ONCE EVEN THOUGH THEY USE THIS SYRINGE VERY OFTEN."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD SYRINGE LUER-LOK¿ TIP RUBBER STOPPER WAS FOUND DEFORMED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS IS A PHARMACY AND IT HAPPENED HERE, BEFORE USE. THE PACKAGE IS OPEN AND THE SYRINGE UNUSED. THE RUBBER STOPPER LOCATED ON THE PLUNGER AT THE BOTTOM OF THE SYRINGE IS DEFORMED. IT HAS HAPPENED ONLY ONCE EVEN THOUGH THEY USE THIS SYRINGE VERY OFTEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344986 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9210930 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other