BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML 21G 1-1/4IN

    MDR report key: 11917989 · Received June 1, 2021

    Report

    Report Number
    2243072-2021-01568
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 16, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    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: 2021-05-11. H6: INVESTIGATION SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1101052. VISUAL INSPECTION OF RECEIVED SAMPLE: THERE WAS A FOREIGN MATERIAL. INFRARED SPECTROMETRY (IR) ANALYSIS: BASED ON INFRARED SPECTROMETRY (IR) ANALYSIS OF THE COMPLAINT SAMPLE, WE FOUND THAT IT IS SAME COMPONENT WITH RAW MATERIAL OF STOPPER (TALC). SBDM CONDUCTED VISUAL INSPECTION, TOTAL 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT (SYRINGE 10ML 21G 1-1/4IN, LOT NO. 1012232, 1101052 & 1101062), THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 1101052), THERE IS NO ISSUE WHILE MANUFACTURING. FROM INVESTIGATIONS, THE 10ML SYRINGE STOPPER COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE AND HIGH PRESSURE. IT IS LIKELY THAT TPE (THERMO PLASTIC ELASTOMER, RAW MATERIAL OF 10ML SYRINGE STOPPER) BURR MAY BE FORMED IN THE HIGH PRESSURE WHILE INJECTION PROCESS. ALSO, THE BURR WAS SEPARATED IN THE SYRINGE ASSEMBLY PROCESS AND STOCKED IN THE SYRINGE TIP DUE TO STATIC ELECTRONICS WHILE SYRINGE ASSEMBLY MACHINE. THE FM IS BURR OF STOPPER AND THE SYRINGE ASSEMBLY LINE INSPECTOR COULD NOT FIND THE FM AND IT CAUSED THIS COMPLAINT CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE SYRINGE 10ML 21G 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATERIAL."

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 FOREIGN MATTER WAS FOUND IN THE SYRINGE 10ML 21G 1-1/4IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOREIGN MATERIAL"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808422 SYRINGE 10ML 21G 1-1/4IN PISTON SYRINGE FMF BECTON DICKINSON 1101052

    Patients

    Seq Age Sex Outcome Treatment
    1