BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7563052 · Received June 1, 2018

    Report

    Report Number
    1213809-2018-00330
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    May 11, 2018
    Report Date
    September 15, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    00382903052691
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS COMPLAINT WAS OPENED AS A RESULT OF BD ASSOCIATE SUSTAINED AN ACCIDENTAL NEEDLE STICK INJURY DURING SAMPLES INVESTIGATION FOR PR TW 163928. CRS 1844201A WAS ALSO OPENED TO CAPTURE ALL ACTIVITIES AND FOLLOW UP MADE TO CONSUMER, BD ASSOCIATE , 3RD PARTY HCP AND BD LEGAL DEPARTMENT- SEE ATTACHED CRS 1844201A FOR DETAILS. DHR REVIEW FOR BATCH 6201980 (P/N (B)(4). MANUFACTURING DATES: 08/14/2016 TO 08/17/2016. BATCH QUANTITY WAS 255,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6201980 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: THIS COMPLAINT WAS OPENED AS A RESULT OF BD ASSOCIATE SUSTAINED AN ACCIDENTAL NEEDLE STICK INJURY DURING SAMPLES INVESTIGATION FOR (B)(4). CORRECTION: TYPE OF REPORTABLE EVENTS CORRECTED TO: SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE RECAPPING THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE A NEEDLE STICK INJURY OCCURRED TO THE RIGHT RING FINGER. INJURY OCCURED AFTER USE. NO FURTHER INFORMATION GIVEN. NO REPORTS OF MEDICAL INTERVENTION NOTED.

    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.

    Additional Manufacturer Narrative · 1

    DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS. DEVICE RETURNED TO MANUFACTURE: NO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE RECAPPING THE BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE A NEEDLE STICK INJURY OCCURRED TO THE RIGHT RING FINGER. INJURY OCCURED AFTER USE. NO FURTHER INFORMATION GIVEN. NO REPORTS OF MEDICAL INTERVENTION NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE RECAPPING THE BD INTEGRA SYRINGE WITH DETACHABLE NEEDLE A NEEDLE STICK INJURY OCCURRED TO THE RIGHT RING FINGER. INJURY OCCURED AFTER USE. NO FURTHER INFORMATION GIVEN. NO REPORTS OF MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403251 BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 6201980 00382903052691

    Patients

    Seq Age Sex Outcome Treatment
    1 Other