BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML W/O

    MDR report key: 11720985 · Received April 23, 2021

    Report

    Report Number
    2243072-2021-01254
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 27, 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: 2021-03-29 H6: INVESTIGATION SUMMARY A SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1010122. FROM VISUAL INSPECTION, SBDM SUPPOSE THAT IT IS PARTICLE OF RUBBER PORT INSIDE OF THE SYRINGE AS OF THE SAME MATERIAL OF RUBBER PORT IN THE VIAL. INFRARED SPECTROMETRY (IR) TEST: FROM INFRARED SPECTROMETRY (IR) ANALYSIS OF THE COMPLAINT SAMPLE, THE FM IS SAME COMPONENT WITH MATERIAL OF RUBBER PORT IN THE VIAL (POLYISOBUTYLENE, AVERAGE MV CA. 2,700,000, CIS WHICH IS A SYNTHETIC RUBBER). HOUSE SAMPLE INSPECTION: SBDM CHECKED 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT (SYRINGE 50ML W/O, LOT NO. 1006013, 1010122 & 1011032), STORED IN THE COMPANY, THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 1010122), THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SIMILAR ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATION, THE FM IS SAME COMPONENT WITH MATERIAL OF RUBBER PORT IN THE VIAL (POLYISOBUTYLENE, AVERAGE MV CA. 2,700,000, CIS WHICH IS A SYNTHETIC RUBBER). THE LIKELY CAUSE IS THAT THE NEEDLE WAS PIERCED THROUGH THE RUBBER PORT, FRAGMENT OF RUBBER PORT SEPARATED AND THEN IT FLOWED INTO THE SYRINGE. IT MIGHT BE OCCURRED WHEN TOO SHARP INJECTION HOLE IN THE NEEDLE IS PIERCED TOO SOFT VIAL RUBBER. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 50ML W/O EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS FOREIGN MATERIAL ON THE GASKET. THE CUSTOMER USED IT TO INJECT PROPOFOL.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: 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 THE SYRINGE 50ML W/O EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA/NEEDLE/SYRINGE OR OTHER FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS FOREIGN MATERIAL ON THE GASKET. THE CUSTOMER USED IT TO INJECT PROPOFOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616487 SYRINGE 50ML W/O SYRINGE FMF BECTON DICKINSON 1010122

    Patients

    Seq Age Sex Outcome Treatment
    1