BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML 18G 1-1/2IN SBDM

    MDR report key: 7389224 · Received April 2, 2018

    Report

    Report Number
    2243072-2018-00178
    Event Type
    Malfunction
    Date Received
    April 2, 2018
    Date of Event
    March 27, 2018
    Report Date
    May 16, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO SBDM, THE LOT NUMBER IS UNKNOWN. SBDM CONDUCTED VISUAL INSPECTION OF THE COMPLAINT SAMPLE, INITIAL ASSESSMENT POINTS TO THE FM BEING PLASTIC PIECES. HOUSE SAMPLE INSPECTION: SBDM CONDUCTED INSPECTION ON 5 POSSIBLE LOT (1802063, 1802083, 1803053, 1803063 AND 1803073), 30 PCS INSPECTED PER LOT. NO FOREIGN MATTER WAS OBSERVED. INFRARED SPECTROMETRY (IR) ANALYSIS: SBDM CONDUCTED IR ANALYSIS ON THE FOREIGN MATTER. BASED ON IR RESULTS, THE MATERIAL OF FM WAS POLYPROPYLENE, THE SAME RAW MATERIAL OF BARREL. DEVICE HISTORY RECORD REVIEW: SBDM REVIEWED THE MANUFACTURING RECORD OF COMPLAINT SAMPLE, BASED ON 5 POSSIBLE LOTS (1802063, 1802083, 1803053, 1803063 AND 1803073), NO ABNORMALITY WAS OBSERVED. SBDM COMPLAINT RECORD REVIEW: SBDM REVIEWED CUSTOMER COMPLAINT RECORD (POSSIBLE LOT NO. 1802063, 1802083, 1803053, 1803063 AND 1803073), THERE IS NO REPEAT SAME ISSUE FOR SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: THE LIKELY CAUSE IS DURING SYRINGE ASSEMBLY PROCESS, WHILE THE BARREL WAS FEEDING TO SYRINGE ASSEMBLY MACHINE. THERE IS POSSIBILITY OF THE BARREL WAS NOT MOVING TO THE INDEX OF SYRINGE ASSEMBLY MACHINE PROPERLY. THIS CAUSES THE BARREL TO BE UNDER PRESSURE AND SUBSEQUENTLY THE BARREL WAS BROKEN BY THE INDEX. THE BROKEN PLASTIC PIECE THEN DROPPED INTO THE BARREL, AND THIS FM WAS MISSED OUT DURING OUTGOING INSPECTION. CORRECTIVE ACTION: 1. SBDM HAD QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. 2. SBDM IMPLEMENTED TIGHTENED PRODUCT & PROCESS INSPECTION AND STRENGTHENING QUALITY INSPECTION FOR SYRINGE MANUFACTURING PROCESS. 3. SBDM WILL DO MAINTENANCE OF THE INDEX OF SYRINGE ASSEMBLY MACHINE TO FIT BETWEEN FEEDER AND INDEX. 4. SBDM IMPLEMENTED 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. 5. SBDM INSTALLED GUARD ON THE SYRINGE ASSEMBLY MACHINE TO PREVENT FM (BROKEN PARTICLE). CONCLUSION: BASED ON INVESTIGATION, INFRARED SPECTROMETRY ANALYSIS OF THE FM CONCLUDED THE MATERIAL TO BE POLYPROPYLENE, THE SAME RAW MATERIAL OF BARREL. THE LIKELY CAUSE IS DURING SYRINGE ASSEMBLY PROCESS, WHILE THE BARREL WAS FEEDING TO SYRINGE ASSEMBLY MACHINE. THERE IS POSSIBILITY OF THE BARREL WAS NOT MOVING TO THE INDEX OF SYRINGE ASSEMBLY MACHINE PROPERLY. THIS CAUSES THE BARREL TO BE UNDER PRESSURE AND SUBSEQUENTLY THE BARREL WAS BROKEN BY THE INDEX. THE BROKEN PLASTIC PIECE THEN DROPPED INTO THE BARREL, AND THIS FM WAS MISSED OUT DURING OUTGOING INSPECTION.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: UNKNOWN. 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

    IT WAS REPORTED DURING USE OF THE SYRINGE 50ML 18G 1-1/2IN SBDM THERE WAS FOREIGN MATTER IN THE PATHWAY. THE CONSUMER STATES THERE WAS ¿FOREIGN MATERIAL LIKE PLASTIC MATTER IN THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233968 SYRINGE 50ML 18G 1-1/2IN SBDM HYPODERMIC SYRINGE AND NEEDLE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other