BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL S/C 200

    MDR report key: 10497871 · Received September 4, 2020

    Report

    Report Number
    1213809-2020-00603
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 13, 2020
    Report Date
    September 9, 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

    H.6. INVESTIGATION SUMMARY ONE PHOTO OF A 10ML SYRINGE INSIDE A SEALED BLISTER PACK WAS RECEIVED AN EVALUATED. IT WAS OBSERVED THE STOPPER INSIDE THE SYRINGE WAS WEDGED BETWEEN THE PLUNGER ROD AND BARREL WALL, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE DEFECTIVE RATE IDENTIFIED FOR THIS BATCH IS (B)(4) . NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 0111649 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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. DHR REVIEW: RELEASE DATE: 4/28/2020. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 HAD A BROKEN PLUNGER ROD AND A DEFECTIVE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLUNGER ROD IS MELTED TO THE SIDE OF THE SYRINGE. DETAILS OF COMPLAINT (REPORTED ISSUE): 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. CHC COMPLAINT REFERENCE #: (B)((4). CAT# OF PRODUCT BEING COMPLAINED: BD302995 DESCRIPTION OF PRODUCT: SYRINGE 10CC ONLY LUER-LOK ST 200EA/BX 2BX/CA LOT OR S/N: 0111649 COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO INCIDENT DATE: (B)(6) 2020 HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): 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. COMPLAINT NOTICED: PRIOR TO USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN QTY AFFECTED: 1 EA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO RETURN QTY:"

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL S/C 200 HAD A BROKEN PLUNGER ROD AND A DEFECTIVE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE PLUNGER ROD IS MELTED TO THE SIDE OF THE SYRINGE. DETAILS OF COMPLAINT (REPORTED ISSUE): 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. CHC COMPLAINT REFERENCE #: (B)(4). CAT# OF PRODUCT BEING COMPLAINED: (B)(4). DESCRIPTION OF PRODUCT: SYRINGE 10CC ONLY LUER-LOK ST 200EA/BX 2BX/CA, LOT OR S/N: (B)(4). COMPLAINT CATEGORY: FAIL TO FUNCTION / DEFECTIVE REPORTABLE: NO, INCIDENT DATE: (B)(6) 2020, HOSPITAL COMPLAINT REFERENCE #: (B)(4). DETAILS OF COMPLAINT (REPORTED ISSUE): 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. COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? UNKNOWN. QTY AFFECTED: 1 EA. SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO. RETURN QTY:"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    957006 SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 302995 0111649 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other