BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ 3-PIECE SYRINGE

    MDR report key: 14601986 · Received June 6, 2022

    Report

    Report Number
    3003152976-2022-00250
    Event Type
    Malfunction
    Date Received
    June 6, 2022
    Date of Event
    May 10, 2022
    Report Date
    June 14, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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

    H6. INVESTIGATION SUMMARY: NO SAMPLES OR PICTURES HAVE BEEN RECEIVED TO PERFORM INVESTIGATION. COMPLAINT INVOLVES 50LL SYRINGES WITH REFERENCES 300865 AND LOT NUMBER 2201087. CUSTOMER REPORTS LEAKAGE PAST THE STOPPER. SINCE NO SAMPLES OR PICTURES ARE AVAILABLE FOR INVESTIGATION, TEN RETAINED SAMPLES HAVE BEEN REQUESTED. DHR FROM LOT 2202087 HAS BEEN REVIEWED NOT FINDING ANY ANNOTATION OR DEVIATION REGARDING THE ALLEGED DEFECT. UPON VISUAL INSPECTION OF THE SAMPLES RECEIVED NO DAMAGE CAN BE NOTICED IN ANY OF THE SYRINGES. STOPPER IS CORRECTLY ASSEMBLED IN ALL OF THEM AND NO MOLDING OR OTHER DEFECTS THAT COULD LEAD TO LEAKAGE PAST THE STOPPER EXPERIENCED BY CUSTOMER CAN BE NOTICED. LEAK TEST IS CARRIED OUT WITH THE TEN RETAINED SAMPLES. SAMPLES MEET ISO 7886-1 ANNEX D. ACCORDING TO INSPECTION, 200 UNITS ARE INSPECTED EVERY 2 PALLETS BY QUALITY CONTROL TEAM. IN ADDITION, FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED BY OPERATOR AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. SINCE SAMPLES MEET ISO 7886-1 ANNEX D AND MANUFACTURING RECORDS ESTABLISHED ALL PROCESSES WERE CARRIED OUT NORMALLY, ROOT CAUSE OF THE ALLEGED DEFECT CANNOT BE DETERMINED WITH EVIDENCE. BASED ON ALL THE PREVENTIVE MEASURES AND OUR STRINGENT IN ¿PROCESS INSPECTION PLAN, WE ARE CERTAIN THAT THIS SHOULD BE AN ISOLATED ISSUE AND ANY RECURRENCE IS REALLY UNLIKELY BASED ON NO QUALITY NOTIFICATION WAS OPENED DURING MANUFACTURING PROCESS OF THIS LOT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ 3-PIECE SYRINGE HAD FAULTY PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGING FAULTY OR INCORRECT".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ 3-PIECE SYRINGE LEAKED PAST THE STOPPER/PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKING SYRINGE AT PLUNGER RUBBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184392 BD PLASTIPAK ¿ 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201087

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown