BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 9827492 · Received March 12, 2020

    Report

    Report Number
    1213809-2020-00188
    Event Type
    Malfunction
    Date Received
    March 12, 2020
    Date of Event
    February 21, 2020
    Report Date
    March 18, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K980580
    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

    H.6. 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 LEAKAGE OCCURRED WITH A BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE SYRINGES WERE LEAKY. ON (B)(6)2020 PATIENT REPORTED HER PREVIOUS MEDICATION KIT HAS ABOUT THREE (3) VIALS THAT WERE LEAKY. IT WAS FIRST DISCOVERED THE WEEK OF (B)(6)2020. *PT HAS ALREADY DISCARDED THE VIALS AND DOES HAVE ON HAND TO RETURN. *PT WAS NOT HOME TO PROVIDE LOT# AND EXPIRATION DATE. IN ADDITION TO THE BELOW QUESTIONS, CAN YOU CONFIRM WHETHER THE LEAKING OCCURRED WITH THE DRUG VIAL OR THE SWIFI VIAL (DILUENT). JBF (B)(6)2020- RESPONSE RECEIVED FROM CALL CENTER. 2. DID THE CONSUMER SAY WHERE THE VIAL WAS LEAKING FROM? LEAKING WAS COMING RIGHT THROUGH THE SEALING ON THE NEEDLE. 3. WHEN DID THE VIAL LEAK? WHEN WITHDRAWING THE DOSE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9070752 MEDICAL DEVICE EXPIRATION DATE: 2024-02-29 DEVICE MANUFACTURE DATE: 2019-03-11 MEDICAL DEVICE LOT #: 9076761 MEDICAL DEVICE EXPIRATION DATE: 2024-02-29 DEVICE MANUFACTURE DATE: 2019-03-17 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 LEAKAGE OCCURRED WITH A BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT THE SYRINGES WERE LEAKY. ON 21FEB2020 PATIENT REPORTED HER PREVIOUS MEDICATION KIT HAS ABOUT THREE (3) VIALS THAT WERE LEAKY. IT WAS FIRST DISCOVERED THE WEEK OF 06JAN2020. *PT HAS ALREADY DISCARDED THE VIALS AND DOES HAVE ON HAND TO RETURN. *PT WAS NOT HOME TO PROVIDE LOT# AND EXPIRATION DATE. IN ADDITION TO THE BELOW QUESTIONS, CAN YOU CONFIRM WHETHER THE LEAKING OCCURRED WITH THE DRUG VIAL OR THE SWIFI VIAL (DILUENT). JBF 26FEB2020- RESPONSE RECEIVED FROM CALL CENTER. DID THE CONSUMER SAY WHERE THE VIAL WAS LEAKING FROM? LEAKING WAS COMING RIGHT THROUGH THE SEALING ON THE NEEDLE WHEN DID THE VIAL LEAK? WHEN WITHDRAWING THE DOSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291168 BD SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE. H.10 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Other