BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LL 200 S/C

    MDR report key: 8487939 · Received April 5, 2019

    Report

    Report Number
    1213809-2019-00416
    Event Type
    Malfunction
    Date Received
    April 5, 2019
    Date of Event
    March 8, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD¿ SYRINGE LL 200 S/C LEAKED AT THE SYRINGE TIP WHEN ATTEMPTING TO FILL THE CARTRIDGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿ THIS REPORT REPRESENTS ALL AVAILABLE PRODUCT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. 1. DESCRIPTION OF ISSUE: CONTACT REPORTS INSULIN LEAKED FROM THE SYRINGE TIP, WHERE IT CONNECTS TO THE NEEDLE, WHEN ATTEMPTING TO FILL THE CARTRIDGE, 3. NUMBER OF OCCURRENCES: 1, 4. ITEM NUMBER , 3 ML SYRINGE 309657, 5. PRODUCT LOT NUMBER: 8246727, 6. ARE SAMPLES AVAILABLE FOR INVESTIGATION? O YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES 7. DID ISSUE CAUSE ANY INJURY? NO, 8. MEDICAL INTERVENTION NEEDED? NO.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MFR: 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

    IT WAS REPORTED THAT A BD¿ SYRINGE LL 200 S/C LEAKED AT THE SYRINGE TIP WHEN ATTEMPTING TO FILL THE CARTRIDGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿THIS REPORT REPRESENTS ALL AVAILABLE PRODUCT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DESCRIPTION OF ISSUE: CONTACT REPORTS INSULIN LEAKED FROM THE SYRINGE TIP, WHERE IT CONNECTS TO THE NEEDLE, WHEN ATTEMPTING TO FILL THE CARTRIDGE. NUMBER OF OCCURRENCES: 1. ITEM NUMBER: 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: 8246727. ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. DID ISSUE CAUSE ANY INJURY? NO. MEDICAL INTERVENTION NEEDED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282591 BD SYRINGE LL 200 S/C SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8246727 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other