BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML, 27 GAUGE X 1/2 INCH SYRINGE

    MDR report key: 8625042 · Received May 20, 2019

    Report

    Report Number
    2243072-2019-00972
    Event Type
    Malfunction
    Date Received
    May 20, 2019
    Date of Event
    April 3, 2019
    Report Date
    June 4, 2019
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    PMA / PMN Number
    K980580
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH #7216823. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE BRAND NAME: BD 1ML, 27 GAUGE X 1/2 INCH SYRINGE. MEDICAL DEVICE MANUFACTURER: BD MEDICAL - DIABETES CARE HOLDREGE. MEDICAL DEVICE CATALOG # 305553. MEDICAL DEVICE LOT #: 7216823. MEDICAL DEVICE EXPIRATION DATE: 2022-09-30. UNIQUE IDENTIFIER (UDI) #: 30382903055532. MANUFACTURING LOCATION: BD MEDICAL - DIABETES CARE HOLDREGE. PMA / 510(K)#: K980580. DEVICE MANUFACTURE DATE: 2017-08-04.

    Description of Event or Problem · 0

    MATERIAL NO. 305553 BATCH NO. 7216823. IT WAS REPORTED THAT DURING USE OF THE BD 1ML, 27 GAUGE X 1/2 INCH SYRINGE THE NEEDLE FELL OFF THE SYRINGE AS THE PATIENT WAS MIXING SYLATRON. THERE WAS A POP SOUND FROM AN UNSPECIFIED ITEM THEN THE NEEDLE FELL OFF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT ADVOCATE: PATIENT ADVOCATE CALLED TO REPORT WHEN THE PATIENT WAS MIXING SYLATRON THERE WAS A POP SOUND FROM AN UNSPECIFIED ITEM THEN THE NEEDLE FELL OFF THE SYRINGE. THE PATIENT ADVOCATE DID NOT HAVE COMPLETE INFORMATION AND DETAILS. OUTBOUND CALL WILL BE MADE TO THE CONSUMER TO OBTAIN LOT AND EXP DATE AND QUESTIONS THAT WERE UNKNOWN BY REPORTER AND TO FIND OUT IF THE PRODUCT CAN BE RETRIEVED. SYLATRON DID NOT PATIENT. NO AR/PQC. INFORMATION: SYRINGE IS A BD 1ML, 27 GAUGE X 1/2 INCH. OBTAIN SYRINGE WRAPPER ONLY IF SYRINGE IS REMOVED FROM THE WRAPPER."

    Description of Event or Problem · 0

    MATERIAL NO. 305553. BATCH NO. 7216823. IT WAS REPORTED THAT DURING USE OF THE BD 1ML, 27 GAUGE X 1/2 INCH SYRINGE THE NEEDLE FELL OFF THE SYRINGE AS THE PATIENT WAS MIXING SYLATRON. THERE WAS A POP SOUND FROM AN UNSPECIFIED ITEM THEN THE NEEDLE FELL OFF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT ADVOCATE: PATIENT ADVOCATE CALLED TO REPORT WHEN THE PATIENT WAS MIXING SYLATRON THERE WAS A POP SOUND FROM AN UNSPECIFIED ITEM THEN THE NEEDLE FELL OFF THE SYRINGE. THE PATIENT ADVOCATE DID NOT HAVE COMPLETE INFORMATION AND DETAILS. OUTBOUND CALL WILL BE MADE TO THE CONSUMER TO OBTAIN LOT AND EXP DATE AND QUESTIONS THAT WERE UNKNOWN BY REPORTER AND TO FIND OUT IF THE PRODUCT CAN BE RETRIEVED. SYLATRON DID NOT PATIENT. NO AR/PQC INFORMATION: SYRINGE IS A BD 1ML, 27 GAUGE X 1/2 INCH. OBTAIN SYRINGE WRAPPER ONLY IF SYRINGE IS REMOVED FROM THE WRAPPER."

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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

    MATERIAL NO. UNKNOWN. BATCH NO. UNKNOWN. IT WAS REPORTED THAT DURING USE OF THE UNSPECIFIED BD 1ML, 27 GAUGE X 1/2 INCH SYRINGE THE NEEDLE FELL OFF THE SYRINGE AS THE PATIENT WAS MIXING SYLATRON. THERE WAS A POP SOUND FROM AN UNSPECIFIED ITEM THEN THE NEEDLE FELL OFF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE PATIENT ADVOCATE: PATIENT ADVOCATE CALLED TO REPORT WHEN THE PATIENT WAS MIXING SYLATRON THERE WAS A POP SOUND FROM AN UNSPECIFIED ITEM THEN THE NEEDLE FELL OFF THE SYRINGE. THE PATIENT ADVOCATE DID NOT HAVE COMPLETE INFORMATION AND DETAILS. OUTBOUND CALL WILL BE MADE TO THE CONSUMER TO OBTAIN LOT AND EXP DATE AND QUESTIONS THAT WERE UNKNOWN BY REPORTER AND TO FIND OUT IF THE PRODUCT CAN BE RETRIEVED. SYLATRON DID NOT PATIENT. NO AR/PQC INFORMATION: SYRINGE IS A BD 1ML, 27 GAUGE X 1/2 INCH. OBTAIN SYRINGE WRAPPER ONLY IF SYRINGE IS REMOVED FROM THE WRAPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419475 BD 1ML, 27 GAUGE X 1/2 INCH SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 7216823

    Patients

    Seq Age Sex Outcome Treatment
    1 Other