BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SYRINGE WITH NEEDLE

    MDR report key: 8056389 · Received November 9, 2018

    Report

    Report Number
    2243072-2018-01585
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Date of Event
    October 17, 2018
    Report Date
    January 28, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES WERE SENT TO SBDM, THE LOT NUMBER AFFECTED IS UNKNOWN. FROM THE PICTURE PROVIDED TO SBDM, SBDM NOTICED BRIGHT GREY COLOR FOREIGN MATTER (FM) INSIDE THE SYRINGE. INVESTIGATION CONCLUSION: SBDM ASSUME THAT THE FM IS RUBBER, WHICH MOST LIKELY WAS DETACHED FROM THE VIAL CAP, AS SBDM NOTICED THE FM COLOR IS THE SAME COLOR WITH THE RUBBER OF THE VIAL CAP. THIS COMPLAINT LOOKS SIMILAR TO ANOTHER COMPLAINT WHICH SBDM INVESTIGATED BEFORE. SBDM INSPECTED 25 PCS OF RETAINED SAMPLES FROM 5 LOTS (1808293, 1808303, 1808313, 1810023 AND 1810093), NO FM WAS OBSERVED. SBDM REVIEWED MANUFACTURED RECORDS FOR POSSIBLE LOT 1808293, 1808303, 1808313, 1810023 AND 1810093, NO ABNORMALITY WAS OBSERVED. SBDM REVIEWED INTERNAL COMPLAINT RECORDS FROM POSSIBLE LOT 1808293, 1808303, 1808313, 1810023 AND 1810093, THERE IS NO SAME ISSUE WITH THESE LOTS. ROOT CAUSE DESCRIPTION: SBDM CONSIDER THAT THIS CASE IS SIMILAR CASE TO THE ONE PREVIOUSLY INVESTIGATED. THE LIKELY CAUSE IS THE RUBBER IN THE CAP OF VIAL WAS DETACHED WHEN THE USER HAD INJECTED A SYRINGE IN THE VIAL. SUBSEQUENTLY, THE RUBBER WAS DETACHED BY NEEDLE AND FLOWED INTO THE SYRINGE. ANOTHER POSSIBILITY IS THE FM COULD GET INTO THE SYRINGE WHILE CHANGING NEEDLE, BUT THIS IS AT A LOW POSSIBILITY. RATIONALE: CORRECTIVE ACTIONS: 1. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. 2. SBDM WILL IMPLEMENT TIGHTENED PRODUCT & PROCESS INSPECTION AND STRENGTHENING QUALITY INSPECTION FOR SYRINGE MANUFACTURING PROCESS. 3. SBDM WILL IMPLEMENT 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND ALSO HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN THE BD¿ SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (B)(6). 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 FOREIGN MATTER WAS FOUND IN THE BD¿ SYRINGE WITH NEEDLE. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893981 BD¿ SYRINGE WITH NEEDLE SYRINGE WITH NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    0 Other