BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 10497874 · Received September 4, 2020

    Report

    Report Number
    1213809-2020-00604
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 14, 2020
    Report Date
    September 16, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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: 2020-09-07. H.6. INVESTIGATION SUMMARY THREE PHOTOS AND ONE 10ML SYRINGE IN A FULLY SEALED BLISTER PACK CONFIRMED TO BE FROM BATCH 0111649 WAS RECEIVED AND EVALUATED. IT WAS OBSERVED THE STOPPER INSIDE THE SYRINGE WAS NOT FULLY SECURED TO THE PLUNGER ROD, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE INSECURE STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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. DHR REVIEW: RELEASE DATE: (B)(6) 2020. RELEASED QUANTITY WAS 502,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 0111649 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 HAD A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLUNGER WAS MELTED TO THE SIDE OF THE SYRINGE. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: TOH WOULD LIKE TO REPORT AND BRING TO YOUR ATTENTION A PRODUCT MALFUNCTION WITH BD302995 SYRINGE; DISTRIBUTED THROUGH CARDINAL HEALTH CANADA. AS YOU CAN SEE IN THE PHOTOS BELOW, THE PLUNDER IS MELTED TO THE SIDE OF THE SYRINGE. THE PRODUCT HAS BEEN STORED IN THE EVENT THAT YOU OR THE MANUFACTURER (BECTON DICKINSON) NEED TO VIEW IT. THUS FAR WE HAVE ONLY EXPERIENCED THIS WITH THE SYRINGE SHOWN BELOW (LOT#0111649) AND NO STAFF NOR PATIENTS WERE IMPACTED AS THE DAMAGE WAS NOTICED BEFORE OPENING THE PACKAGE. QUESTIONS/INQUIRIES: COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1 - COMPLAINT DETERMINATION TREE ¿ (NASSC-RCC-001)".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 HAD A DAMAGED PLUNGER ROD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLUNGER WAS MELTED TO THE SIDE OF THE SYRINGE. EVENT DESCRIPTION PER ATTACHED EMAIL STATES: (B)(6) WOULD LIKE TO REPORT AND BRING TO YOUR ATTENTION A PRODUCT MALFUNCTION WITH BD302995 SYRINGE; DISTRIBUTED THROUGH (B)(4). AS YOU CAN SEE IN THE PHOTOS BELOW, THE PLUNDER IS MELTED TO THE SIDE OF THE SYRINGE. THE PRODUCT HAS BEEN STORED IN THE EVENT THAT YOU OR THE MANUFACTURER (BECTON DICKINSON) NEED TO VIEW IT. THUS FAR WE HAVE ONLY EXPERIENCED THIS WITH THE SYRINGE SHOWN BELOW (LOT#0111649) AND NO STAFF NOR PATIENTS WERE IMPACTED AS THE DAMAGE WAS NOTICED BEFORE OPENING THE PACKAGE. QUESTIONS/INQUIRIES: COMPLAINT RATIONALE: BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX 1 - COMPLAINT DETERMINATION TREE ¿ (NASSC-RCC-001)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957007 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 0111649 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other