BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML ST BULK CONVENIENCE PAK

    MDR report key: 8899499 · Received August 15, 2019

    Report

    Report Number
    1213809-2019-00832
    Event Type
    Malfunction
    Date Received
    August 15, 2019
    Date of Event
    July 30, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097013
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO AND 40 LOOSE 1ML SYRINGES WERE RECEIVED AND EVALUATED. ALL THE SAMPLES RECEIVED WERE OBSERVED TO HAVE CLOUDY TIPS AND FOUR OF THE SAMPLES WERE ALSO OBSERVED TO HAVE SLIGHTLY ROLLED SCALES. ALL THE SAMPLES RECEIVED WERE ACCEPTABLE PER PRODUCT SPECIFICATION. CLOUDY TIPS ARE A RESULT OF NORMAL MOLDING PROCESS. OVER TIME A SMALL AMOUNT OF PLASTIC BUILD-UP OR RESIDUE OCCURS IN THE MOLD CAUSING THIS DEFECT. IT IS REMEDIED BY POLISHING THE MOLD. THE CLOUDY TIP DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. CLOUDY TIPS ARE A RESULT OF THE NORMAL MOLDING PROCESS. THE POTENTIAL ROOT CAUSE FOR THE ROLLED SCALE DEFECT IS ASSOCIATED WITH THE PRINTING PROCESS. SINCE THE CLOUDY TIP DEFECTS OBSERVED ARE CONSIDERED COSMETIC AND ACCEPTABLE, NO CORRECTIVE ACTIONS ARE NECESSARY. SINCE THE ROLLED SCALE DEFECTS OBSERVED ARE WITHIN THE ACCEPTABLE LIMITS, NO CORRECTIVE ACTIONS ARE NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1ML ST BULK CONVENIENCE PAK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309701 BATCH NO. 8338895, 9003600, 9037699, 9037716, 9037717, 9091734, 9127543. PER EMAIL: WE NEED TO RETURN ALL THESE SYRINGES FROM BD, AS THEY HAVE A STRANGE WHITE RESIDUE WITHIN THE TOP OF EVERY SYRINGE. BD 1ML SYRINGE SLIP TIP CONV TRAY LOT # 8338895, 9003600, 9037699, 9037716, 9037717, 9091734 AND 9127543.

    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 #: 8338895. MEDICAL DEVICE EXPIRATION DATE: 2023-11-30. DEVICE MANUFACTURE DATE: 2019-01-02. MEDICAL DEVICE LOT #: 9003600. MEDICAL DEVICE EXPIRATION DATE: 2023-12-31. DEVICE MANUFACTURE DATE: 2019-02-21. MEDICAL DEVICE LOT #: 9037699. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2019-03-01. MEDICAL DEVICE LOT #: 9037716. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2019-03-01. MEDICAL DEVICE LOT #: 9037717. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2019-03-01. MEDICAL DEVICE LOT #: 9091734. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2019-05-15. MEDICAL DEVICE LOT #: 9127543. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2019-05-30. 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 AN UNSPECIFIED NUMBER OF SYRINGE 1ML ST BULK CONVENIENCE PAK EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309701, BATCH NO. 8338895, 9003600, 9037699, 9037716, 9037717, 9091734, 9127543. PER EMAIL: WE NEED TO RETURN ALL THESE SYRINGES FROM BD, AS THEY HAVE A STRANGE WHITE RESIDUE WITHIN THE TOP OF EVERY SYRINGE. BD 1ML SYRINGE SLIP TIP CONV TRAY. LOT #: 8338895, 9003600, 9037699, 9037716, 9037717, 9091734, 9127543.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690177 SYRINGE 1ML ST BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other