BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL

    MDR report key: 9354776 · Received November 21, 2019

    Report

    Report Number
    1213809-2019-01144
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 29, 2019
    Report Date
    January 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TWO LOOSE 10ML SYRINGES AND A SINGLE OPENED PACKAGE FROM BATCH #9170934 (P/N 302995) WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. BOTH SYRINGES WERE OBSERVED TO HAVE LONG CRACKS OUTSIDE THE SCALE MARKINGS. THE CRACKS EXTENDED FROM THE EDGE AT THE BOTTOM OF THE BARREL LENGTHWISE DOWN TO EQUIVALENT OF 7ML MARKINGS ON ONE SAMPLE AND 9ML MARKINGS ON THE OTHER SAMPLE. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. DURING PRODUCTION OF THE REPORTED BATCH, AN ISSUE WAS IDENTIFIED AND ADDITIONAL MEASURES WERE TAKEN TO ASSURE RELEASE OF THE PRODUCT. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9170934 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO.: 302995 BATCH NO.: 9170934 IT WAS REPORTED THAT DURING USE OF THE BD SYRINGE 10ML LL TWO OF THE SYRINGES THE STAFF WENT TO USE WERE CRACKED AND THE SALINE WAS LEAKING THROUGH THE SIDE OF THE BARREL. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO OF THE SYRINGES THE STAFF WENT TO USE WERE CRACKED AND THE SALINE WAS LEAKING THROUGH THE SIDE OF THE BARREL.

    Additional Manufacturer Narrative · 1

    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

    MATERIAL NO.: 302995 BATCH NO.: 9170934. IT WAS REPORTED THAT DURING USE OF THE BD SYRINGE 10ML LL TWO OF THE SYRINGES THE STAFF WENT TO USE WERE CRACKED AND THE SALINE WAS LEAKING THROUGH THE SIDE OF THE BARREL. THIS OCCURRED ON 2 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TWO OF THE SYRINGES THE STAFF WENT TO USE WERE CRACKED AND THE SALINE WAS LEAKING THROUGH THE SIDE OF THE BARREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154335 BD SYRINGE 10ML LL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9170934 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other