BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY

    MDR report key: 8895768 · Received August 14, 2019

    Report

    Report Number
    1911916-2019-00804
    Event Type
    Malfunction
    Date Received
    August 14, 2019
    Date of Event
    July 29, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051565
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY WAS CLOUDY. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305156 BATCH NO. UNKNOWN (CUSTOMER PROVIDED 8172859 & 8090593) IT WAS REPORTED WHEN PATIENT DREW MEDICATION INTO THE SYRINGE IT TURNED CLOUDY. COMPLAINT DESCRIPTION: PT'S HUSBAND PREPARED GATTEX VIAL AS DIRECTED FOR INJECTION. EVERYTHING LOOKED NORMAL. AS HE WAS TRYING TO PULL UP THE MEDICINE INTO THE SYRINGE AS DIRECTED, THE SOLUTION TURNED CLOUDY. THIS HAD NEVER HAPPENED BEFORE. HE DISCARDED THE VIAL AND USED A NEW ONE AND EVERYTHING WAS FINE WITH THAT VIAL. NO ADVERSE EFFECTS NOTED. NO OTHER INFORMATION KNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8172859. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-06-21. MEDICAL DEVICE LOT #: 8090593. MEDICAL DEVICE EXPIRATION DATE: 2023-06-30. DEVICE MANUFACTURE DATE: 2018-03-31. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY WAS CLOUDY. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305156, BATCH NO. UNKNOWN (CUSTOMER PROVIDED 8172859 & 8090593) IT WAS REPORTED WHEN PATIENT DREW MEDICATION INTO THE SYRINGE IT TURNED CLOUDY. COMPLAINT DESCRIPTION: PT'S HUSBAND PREPARED GATTEX VIAL AS DIRECTED FOR INJECTION. EVERYTHING LOOKED NORMAL. AS HE WAS TRYING TO PULL UP THE MEDICINE INTO THE SYRINGE AS DIRECTED, THE SOLUTION TURNED CLOUDY. THIS HAD NEVER HAPPENED BEFORE. HE DISCARDED THE VIAL AND USED A NEW ONE AND EVERYTHING WAS FINE WITH THAT VIAL. NO ADVERSE EFFECTS NOTED. NO OTHER INFORMATION KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689422 BD HYPODERMIC NEEDLE PRECISIONGLIDE¿ WITHOUT SAFETY HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10 30382903051565

    Patients

    Seq Age Sex Outcome Treatment
    1 Other