BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 9362493 · Received November 22, 2019

    Report

    Report Number
    3003152976-2019-00802
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Date of Event
    November 6, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A TOTAL OF FOUR SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION; ; ONE UNUSED SAMPLE OF 50ML LL WITHOUT BLISTER, TWO UNUSED SAMPLES OF LOT 1902231 WITH AN OPEN BLISTER, AND ONE UNUSED SAMPLE WITH AN OPEN BLISTER OF LOT 1902237. UPON VISUAL INSPECTION OF THE FIRST SAMPLE RECEIVED WITHOUT A BLISTER PACK AND SAMPLES FROM 1902231, A PARTICLE WAS OBSERVED INSIDE THE SYRINGES. USING MAGNIFICATION, THE PARTICLE OBSERVE IN THE FIRST SAMPLE WAS IDENTIFIED TO BE POLYPROPYLENE. INSIDE THE SAMPLES OF LOT 1902231, THE PARTICLE WAS DETERMINED TO BE ELASTIC. WHEN INSPECTING THE SAMPLE FROM LOT 1902237, NO PARTICLES OR FOREIGN MATERIAL WAS OBSERVED INSIDE THE SYRINGE. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THE REPORTED LOTS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE MANUFACTURING LINE HAS A BLOWING VACUUM SYSTEM FOR PARTICLES AND FINAL PRODUCTS FOR THIS REFERENCE AND LOT SIZE 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 POLYPROPYLENE PARTICLE LIKELY ORIGINATED DURING TRANSPORT OF THE PRODUCT INSIDE THE MANUFACTURING EQUIPMENT OR AS A RESULT OF THE PIECE RUBBING AGAINST PARTS OF THE MANUFACTURING MACHINE. THE ORIGIN OF THE ELASTIC PARTICLE COULD NOT BE DETERMINED AS THIS MATERIAL IS NOT CONSISTENT WITH ANY ELEMENT USED WITHIN OUR MANUFACTURING PROCESS. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO TRACK ANY FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARTICULATE MATTER WITHIN THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1905223, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-05-07. MEDICAL DEVICE LOT #: 1902237, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-26. MEDICAL DEVICE LOT #: 1902231, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2019-02-20. 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 BEFORE USE OF THE BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE THERE WAS AN ISSUE WITH FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PARTICULATE MATTER WITHIN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161154 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. SEE SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other