BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE

    MDR report key: 10015233 · Received April 30, 2020

    Report

    Report Number
    8041187-2020-00235
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 10, 2020
    Report Date
    May 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057895
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLUNGER OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE BECAME "STUCK" DURING THE PPD SKIN TEST, AND THE SOLUTION COULD NOT BE PUSHED OUT. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MEDICAL ASSISTANT WAS TRYING TO GIVE A PPD SKIN TEST. SHE WAS ABLE TO DRAW UP THE SOLUTION WITHOUT A PROBLEM. WHEN IT CAME TIME TO GIVE THE INJECTION, WHEN SHE PUSHED THE SYRINGE IN, THE SYRINGE WAS STUCK AND WOULD NOT PUSH OUT THE SOLUTION. MA TOOK OUT THE NEEDLE AND TRIED TO PUSH OUT SOLUTION WITH OUT STICKING THE EMPLOYEE AND IT WAS STILL STUCK AND UNABLE TO GET SOLUTION OUT. MA TRIED WITH ANOTHER NEEDLE AND SYRINGE FROM THE SAME BOX AND SAME PROBLEM OCCURRED AGAIN."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: PISTON SYRINGE. MEDICAL DEVICE TYPE: FMF. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K161170 (NEEDLE). PMA / 510(K)#: K941562 (SYRINGE). 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 THE PLUNGER OF THE BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE BECAME "STUCK" DURING THE PPD SKIN TEST, AND THE SOLUTION COULD NOT BE PUSHED OUT. THIS OCCURRED ON 2 SEPARATE OCCASIONS, BUT THE DATES AND/OR PATIENT INFORMATION ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MEDICAL ASSISTANT WAS TRYING TO GIVE A PPD SKIN TEST. SHE WAS ABLE TO DRAW UP THE SOLUTION WITHOUT A PROBLEM. WHEN IT CAME TIME TO GIVE THE INJECTION, WHEN SHE PUSHED THE SYRINGE IN, THE SYRINGE WAS STUCK AND WOULD NOT PUSH OUT THE SOLUTION. MA TOOK OUT THE NEEDLE AND TRIED TO PUSH OUT SOLUTION WITH OUT STICKING THE EMPLOYEE AND IT WAS STILL STUCK AND UNABLE TO GET SOLUTION OUT. MA TRIED WITH ANOTHER NEEDLE AND SYRINGE FROM THE SAME BOX AND SAME PROBLEM OCCURRED AGAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476322 BD LUER-LOK¿ SYRINGE WITH DETACHABLE BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305789 9267437 30382903057895

    Patients

    Seq Age Sex Outcome Treatment
    1 Other