BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 14192373 · Received April 25, 2022

    Report

    Report Number
    1213809-2022-00232
    Event Type
    Malfunction
    Date Received
    April 25, 2022
    Date of Event
    March 23, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    00382903052691
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: LOT #: 9142817, DEVICE EXPIRATION DATE: 31-MAY-2024, DEVICE MANUFACTURE DATE: 22-MAY-2019; LOT #: 9142818, DEVICE EXPIRATION DATE: 31-MAY-2024, DEVICE MANUFACTURE DATE: 22-MAY-2019. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS THE SYRINGE WITH THE CANNULA MISSING, THE CUTTER HAS BEEN ACTIVATED THROUGH THE STOPPER AND AN UNKNOWN THE FLUID IS PRESENT BETWEEN THE OUTER PLUNGER ROD AND THE INSIDE OF THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305269, POSSIBLE LOT NUMBERS 9142817 AND 9142818. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR BOTH LOTS. A TREND REVIEW WAS PERFORMED NO ADDITIONAL COMPLAINT REPORTED WITH THE DEFECT NEEDLE RETRACTED PREMATURELY AND ONE ADDITIONAL COMPLAINT REPORTED FOR LEAKAGE REGARDING MATERIAL 305269. POTENTIAL ROOT CAUSE FOR PREMATURE NEEDLE RETRACTION DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCHES 9142817 & 9142818 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ DISPOSABLE SYRINGES HAD NEEDLE RETRACTION ISSUES AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE DISTRIBUTOR REPORTED 2 SYRINGES PREPARED AND 2ND SYRINGE MALFUNCTIONED BY RETRACTING EARLY AS THE PLUNGER RETRACTED BEFORE THE CONTENT WAS DISPENSED FROM THE SYRINGE, THE MAJORITY OF THE DRUG REMAINED IN THE SYRINGE. THE PATIENT WAS UNDER DOSED SINCE SOME OF THE DRUG LEAKED FROM THE SYRINGE. DATE OF OCCURRENCE: (B)(6) 2022.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD LUER-LOK¿ DISPOSABLE SYRINGES HAD NEEDLE RETRACTION ISSUES AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE DISTRIBUTOR REPORTED 2 SYRINGES PREPARED AND 2ND SYRINGE MALFUNCTIONED BY RETRACTING EARLY AS THE PLUNGER RETRACTED BEFORE THE CONTENT WAS DISPENSED FROM THE SYRINGE, THE MAJORITY OF THE DRUG REMAINED IN THE SYRINGE. THE PATIENT WAS UNDER DOSED SINCE SOME OF THE DRUG LEAKED FROM THE SYRINGE. DATE OF OCCURRENCE : (B)(6)2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980568 BD LUER-LOK¿ DISPOSABLE SYRINGE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903052691

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown