BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14311729 · Received May 6, 2022

    Report

    Report Number
    3003152976-2022-00190
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 12, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 03-MAY-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON INSPECTION OF THE PRODUCT, A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. FURTHER EVALUATION IDENTIFIED DAMAGE WITHIN THE BARREL, THE DAMAGE CAUSING THE STOPPER TO BECOME DISTORTED AGAINST THE BARREL WALL WHEN MOVED ACROSS THAT POINT AND RESULTING IN THE LEAKAGE THAT WAS REPORTED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2202078, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, THE DAMAGE OCCURRED DURING THE MANUFACTURING PROCESS MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES HAD DEFECTIVE STOPPERS THAT ALLOWED CYTOSTATIC MEDICATION TO LEAK PAST THEM IN THE LAMINAR FLOW HOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THESE TWO SYRINGES HAD A SEALING PROBLEM AT THE LEVEL OF THE PLUNGER SEAL DURING THE PREPARATION OF CYTOSTATICS. AS A RESULT, THE COLLECTED PRODUCT FLOWED DOWN THE PLUNGER." "THE LEAK OCCURRED IN A LAMINAR FLOW HOOD."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES HAD DEFECTIVE STOPPERS THAT ALLOWED CYTOSTATIC MEDICATION TO LEAK PAST THEM IN THE LAMINAR FLOW HOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THESE TWO SYRINGES HAD A SEALING PROBLEM AT THE LEVEL OF THE PLUNGER SEAL DURING THE PREPARATION OF CYTOSTATICS. AS A RESULT, THE COLLECTED PRODUCT FLOWED DOWN THE PLUNGER." "THE LEAK OCCURRED IN A LAMINAR FLOW HOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073761 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202078

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown