BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LS SP120

    MDR report key: 12425705 · Received September 3, 2021

    Report

    Report Number
    3003152976-2021-00561
    Event Type
    Malfunction
    Date Received
    September 3, 2021
    Date of Event
    August 2, 2021
    Report Date
    September 28, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: 2021-08-17 H6: INVESTIGATION SUMMARY SAMPLES AND PHOTOS RECEIVED FOR INVESTIGATION. SAMPLES RECEIVED BELONG TO LOT NUMBERS 2012054, 2010037, 2101043, 2010038, 2101074, REFERENCE 303172 (1ML SYRINGES). UPON VISUAL INSPECTION OF THE SAMPLES, AIR BUBBLES IN THE BOTTOM OF THE TIP OF THE SYRINGES WERE SEEN IN SAMPLES FROM ALL THE LOTS MENTIONED ABOVE. NO FOREIGN MATTER IN SYRINGES FROM LOTS 2012054, 2010037, 2010038 AND 2101074. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2010037, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE 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 AIR BUBBLES LIKELY GENERATED DURING THE MOLDING PROCESS. WHEN AIR ENTERS THE MOLDING, BUBBLES CAN BE PRODUCED, AS SEEN IN THE PRODUCT REPORTED. MOLDING PARAMETERS WERE REVIEWED FOR THE MOLD THE SYRINGES WERE MANUFACTURED IN; ALL LIMITS WERE VERIFIED TO BE WITHIN SPECIFICATION. INJECTION MACHINES UNDERGO ROUTINE CLEANINGS AND MAINTENANCE ACCORDING TO PROCEDURE. THIS IS CONSIDERED TO BE A COSMETIC DEFECT. BASED ON THE PREVENTIVE MEASURES IN PLACE AND THE CURRENT INSPECTION PROCESS, THIS IS BELIEVED TO BE AN ISOLATED ISSUE WITH AN UNLIKELY RECURRENCE. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT TO INCREASE AWARENESS OF THIS MATTER. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 300 SYRINGE 1ML LS SP120 EXPERIENCED FOREIGN MATTER WITHIN A FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBUBBLES NOTED TO BE IN MULTIPLE SYRINGES OVER DIFFERENT BATCHES BEING USED. BUBBLES NOT NOTICEABLE UNTIL VACCINE IS DRAWN INTO SYRINGE. CONCERN AT ACCURACY OF DOSE IS AFFECTED.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2011074. MEDICAL DEVICE EXPIRATION DATE: 2025-10-31. DEVICE MANUFACTURE DATE: 2021-03-01. MEDICAL DEVICE LOT #: 2101043. MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. DEVICE MANUFACTURE DATE: 2021-10-5. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2021-09-03. MEDICAL DEVICE LOT #: 2010037. MEDICAL DEVICE EXPIRATION DATE: 2025-09-30. DEVICE MANUFACTURE DATE: 2020-10-07. 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 300 SYRINGE 1ML LS SP120 EXPERIENCED FOREIGN MATTER WITHIN A FLUID PATH COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MICROBUBBLES NOTED TO BE IN MULTIPLE SYRINGES OVER DIFFERENT BATCHES BEING USED. BUBBLES NOT NOTICEABLE UNTIL VACCINE IS DRAWN INTO SYRINGE. CONCERN AT ACCURACY OF DOSE IS AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318212 SYRINGE 1ML LS SP120 SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1