BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 9262101 · Received October 31, 2019

    Report

    Report Number
    1911916-2019-01145
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 16, 2019
    Report Date
    November 13, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051114
    PMA / PMN Number
    K021475
    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

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER WOULD NOT PULL BACK DURING USE WITH A BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS). IT WAS REPORTED THERE WAS A NEEDLE ISSUE CAUSING THE PLUNGER ON THE SYRINGE TO NOT PULL BACK. 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTED NEEDLE/SYRINGE ISSUE. CUSTOMER REPORTED PLUNGER ON SYRINGE WOULD NOT PULL BACK. 2. NUMBER OF OCCURRENCES: 1. 3. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 4. 4. ITEM NUMBER: BD 26 G, 1/2¿ NEEDLE ¿ 305111. 5. PRODUCT LOT NUMBER: 83615. 6. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? O NO. CUSTOMER CANNOT OBTAIN AS CUSTOMER DISCARDED SYRINGE 7. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. 8. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER WOULD NOT PULL BACK DURING USE WITH A BD PRECISIONGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) IT WAS REPORTED THERE WAS A NEEDLE ISSUE CAUSING THE PLUNGER ON THE SYRINGE TO NOT PULL BACK. DESCRIPTION OF ISSUE: CUSTOMER REPORTED NEEDLE/SYRINGE ISSUE. CUSTOMER REPORTED PLUNGER ON SYRINGE WOULD NOT PULL BACK. NUMBER OF OCCURRENCES: 1. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 4. ITEM NUMBER: BD 26 G, 1/2¿ NEEDLE ¿ 305111. PRODUCT LOT NUMBER: 83615. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? NO. CUSTOMER CANNOT OBTAIN AS CUSTOMER DISCARDED SYRINGE. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? ¿ NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053365 BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 30382903051114

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other