BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/O DN

    MDR report key: 8782733 · Received July 11, 2019

    Report

    Report Number
    1213809-2019-00735
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 26, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS RECEIVED AND EVALUATED. THE PHOTO DEPICTED A SINGLE LOOSE 1ML LL SYRINGE AND A PIECE OF TOP WEB FROM A BLISTER PACKAGE, CONFIRMED TO BE FROM BATCH #9101705 (P/N 309628). THE BARREL WAS OBSERVED TO HAVE NUMEROUS BLACK SPECK PARTICLES OF VARYING SIZE THROUGHOUT THE WALL. THE PARTICLES APPEARED TO BE EMBEDDED IN THE BARREL¿S PLASTIC. FURTHERMORE, 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. ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO, ONE LOOSE 1ML SYRINGE AND ONE TOP WEB FROM BATCH 9101705 (B)(4) WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THERE WERE MULTIPLE BROWN AND BLACK EMBEDDED FOREIGN MATTER PARTICLES THROUGHOUT THE WALLS OF THE BARREL AND IN THE FLANGE. THE PARTICLES APPEARED TO BE BURNT PLASTIC WITH MULTIPLE PARTICLES LARGER THAN LEVEL 3 IN SIZE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. THE BARREL WAS FROM MOLD L-78 CAVITY 13. 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. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FM IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. PER PROCEDURE, AFTER START UP, ALL MOLDED PARTS ARE SCRAPPED UNTIL NO DEGRADED PLASTIC IS OBSERVED. IF THIS IS NOT PERFORMED THOROUGHLY A PIECE WITH THIS CONDITION CAN GET THROUGH. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9101705 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE 1ML LL W/O DN WAS FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628, BATCH NO.: 9101705. IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE BARREL OF THE SYRINGE. PRODUCT DEFECT WAS DETERMINED FROM PHOTO. PER COMPLAINT FORM: CUSTOMER SENT AN EMAIL REQUESTING WHAT TO DO ABOUT PRODUCT. THEY SHARED AN IMAGE WITH THE PRODUCT AND ALL THE INFORMATION. CUSTOMER HAS KEPT THE PRODUCT IN THEIR OFFICE.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE SYRINGE 1ML LL W/O DN WAS FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628 BATCH NO.: 9101705. IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE BARREL OF THE SYRINGE. PRODUCT DEFECT WAS DETERMINED FROM PHOTO. PER COMPLAINT FORM: CUSTOMER SENT AN EMAIL REQUESTING WHAT TO DO ABOUT PRODUCT. THEY SHARED AN IMAGE WITH THE PRODUCT AND ALL THE INFORMATION. CUSTOMER HAS KEPT THE PRODUCT IN THEIR OFFICE.

    Additional Manufacturer Narrative · 1

    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 HAS BEEN REPORTED THAT ONE SYRINGE 1ML LL W/O DN WAS FOUND CONTAINING FOREIGN MATTER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309628, BATCH NO.: 9101705. IT WAS REPORTED THAT THERE WAS FOREIGN MATTER ON THE BARREL OF THE SYRINGE. PRODUCT DEFECT WAS DETERMINED FROM PHOTO. PER COMPLAINT FORM: CUSTOMER SENT AN EMAIL REQUESTING WHAT TO DO ABOUT PRODUCT. THEY SHARED AN IMAGE WITH THE PRODUCT AND ALL THE INFORMATION. CUSTOMER HAS KEPT THE PRODUCT IN THEIR OFFICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576623 SYRINGE 1ML LL W/O DN PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9101705 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other