BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL

    MDR report key: 10107305 · Received June 1, 2020

    Report

    Report Number
    3003152976-2020-00233
    Event Type
    Malfunction
    Date Received
    June 1, 2020
    Date of Event
    May 12, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/1/2020, H.6. INVESTIGATION: SAMPLES WERE RECEIVED FOR INVESTIGATION BY OUR QUALITY ENGINEER. 5 SEALED SAMPLES OF 10LL LOT 1911008, 5 SEALED SAMPLES OF 10LL LOT 2001006 AND 5 SEALED SAMPLES OF 10LL LOT 2001007 FOR EVALUATION. UPON VISUAL INSPECTION OF ALL THESE SAMPLES RECEIVED, NO EXCESS OF SILICONE CAN BE OBSERVED IN ANY OF THEM. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE POSSIBLE LOT NUMBERS 1911008, 2001006 AND 2001007 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED AND THEREFORE, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 10ML LL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED THAT THE BLACK TIP OF THE PLUNGER ON SOME OF THE STERILE 5ML AND 10ML SYRINGES APPEAR TO HAVE AN EXCESS RESIDUE COVERING THEM. THIS IS OILY IN APPEARANCE. THE CURRENT BATCH NUMBERS FOR THE 10ML SYRINGES WHICH WE HAVE IN STOCK ARE AS FOLLOWS: 1911008, 2001006. WE USE THE SYRINGES TO PREPARE STERILE PRODUCTS IN OUR MANUFACTURING UNITS.

    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 #: 1911008, MEDICAL DEVICE EXPIRATION DATE: 2024-10-31, DEVICE MANUFACTURE DATE: 2019-11-18. MEDICAL DEVICE LOT #: 2001006, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-13. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGES 10ML LL EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED THAT THE BLACK TIP OF THE PLUNGER ON SOME OF THE STERILE 5ML AND 10ML SYRINGES APPEAR TO HAVE AN EXCESS RESIDUE COVERING THEM. THIS IS OILY IN APPEARANCE. THE CURRENT BATCH NUMBERS FOR THE 10ML SYRINGES WHICH WE HAVE IN STOCK ARE AS FOLLOWS: 1911008, 2001006. WE USE THE SYRINGES TO PREPARE STERILE PRODUCTS IN OUR MANUFACTURING UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568179 SYRINGE 10ML LL SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other