BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML 18G 1-1/2IN

    MDR report key: 12132377 · Received July 7, 2021

    Report

    Report Number
    2243072-2021-01825
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 8, 2021
    Report Date
    July 8, 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

    H6: INVESTIGATION SUMMARY A SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1103122. VISUAL INSPECTION OF RECEIVED SAMPLE: THERE WAS A FM IN THE SYRINGE BARREL. INFRARED SPECTROMETRY (IR) ANALYSIS: BASED ON INFRARED SPECTROMETRY (IR) ANALYSIS OF THE COMPLAINT SAMPLE, THE FM IS SAME COMPONENT WITH RAW MATERIAL OF STOPPER (TALC). HOUSE SAMPLE INSPECTION: SBDM CONDUCTED VISUAL INSPECTION, TOTAL 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT (SYRINGE 50ML 18G 1-1/2IN, LOT NO. 1103113, 1103122 & 1103152), THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 1103122), THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE WAS NO SIMILAR ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: FROM INVESTIGATIONS, THE 50ML SYRINGE STOPPER COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE AND HIGH PRESSURE. IT IS LIKELY THAT 50ML SYRINGE STOPPER WAS NOT EJECTED FROM MOLD AND PRESSED AGAIN BY MOLD IN THE INJECTION PROCESS. SO, PRESSED STOPPER MIGHT BE FORMED IN THE HIGH PRESSURE. ALSO, THE PRESSED STOPPER WAS ATTACHED ON THE OTHER STOPPER COMPONENT AND SUPPLIED IN THE SYRINGE ASSEMBLY PROCESS. SO, THE FM IS LIKELY PRESSED INTO STOPPER, AND THE SYRINGE ASSEMBLY LINE INSPECTOR COULD NOT FIND THE FM AND IT CAUSED THIS COMPLAINT CASE. CORRECTIVE ACTIONS: 1. QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE MANUFACTURING PROCESS WORKERS AND QUALITY INSPECTORS. 2. CONDUCT INTENSIVE MAINTENANCE & CLEANING FOR 50ML SYRINGE STOPPER INJECTION MOLD. 3. MONITORING OF SYRINGE MANUFACTURING PROCESS TO SEE IF THE SAME COMPLAINT CASE OCCURS AGAIN. 4. IMPLEMENTING 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS, AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1103122. THERE WAS A FM IN THE SYRINGE BARREL. BASED ON INFRARED SPECTROMETRY (IR) ANALYSIS OF THE COMPLAINT SAMPLE, THE FM IS SAME COMPONENT WITH RAW MATERIAL OF STOPPER (TALC). FROM INVESTIGATIONS, THE 50ML SYRINGE STOPPER COMPONENTS ARE INJECTED IN THE INJECTION MACHINE ON HIGH TEMPERATURE AND HIGH PRESSURE. IT IS LIKELY THAT 50ML SYRINGE STOPPER WAS NOT EJECTED FROM MOLD AND PRESSED AGAIN BY MOLD IN THE INJECTION PROCESS. SO, PRESSED STOPPER MIGHT BE FORMED IN THE HIGH PRESSURE. ALSO, THE PRESSED STOPPER WAS ATTACHED ON THE OTHER STOPPER COMPONENT AND SUPPLIED IN THE SYRINGE ASSEMBLY PROCESS. SO, THE FM IS LIKELY PRESSED INTO STOPPER, AND THE SYRINGE ASSEMBLY LINE INSPECTOR COULD NOT FIND THE FM AND IT CAUSED THIS COMPLAINT CASE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML 18G 1-1/2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS FOREIGN MATERIAL IN THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50ML 18G 1-1/2IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS FOREIGN MATERIAL IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025920 SYRINGE 50ML 18G 1-1/2IN SYRINGE FMF BECTON DICKINSON 1103122

    Patients

    Seq Age Sex Outcome Treatment
    1