BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML 21G 1-1/4IN

    MDR report key: 12021237 · Received June 17, 2021

    Report

    Report Number
    2243072-2021-01698
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 20, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-26 INVESTIGATION SUMMARY A SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1101213. SBDM FOUND THAT THERE WAS BLACK FM ON THE NEEDLE HUB OF THE RECEIVED COMPLAINT SAMPLE. INFRARED SPECTROMETRY (IR) ANALYSIS: BASED ON IR ANALYSIS OF THE COMPLAINT SAMPLE, THE FM IS SAME MATERIAL WITH NEEDLE HUB. HOUSE SAMPLE INSPECTION: SBDM CHECKED THE SAME AND SIMILAR LOT (LOT NO. 1101142, 1101213 & 1101222) HOUSE SAMPLES AS OF THE COMPLAINT SAMPLE, THERE WAS NO SAME CASE ON THE SYRINGE NEEDLE HUB. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE, THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEW THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SAME ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. INCOMING INSPECTION RECORD REVIEW OF BULK NEEDLE: SBDM INVESTIGATE THE BULK NEEDLE INCOMING INSPECTION RECORD (VISUAL INSPECTION AFTER REMOVING NEEDLE COVER) OF COMPLAINT SAMPLE (BULK NEEDLE LOT. 0276358), THERE IS NO ISSUE IN THE INCOMING INSPECTION. ROOT CAUSE: BASED ON THE TEST RESULT OF THE COMPLAINT CASE BY COMPLAINT SAMPLES, FROM IR ANALYSIS THE FM IS SAME MATERIAL WITH NEEDLE HUB. CURRENTLY, SBDM CONDUCT 100% VISUAL INSPECTION IN ASSEMBLY AND PACKING ON THE ASSEMBLY PROCESS. IT IS ASSUME THAT THE INSPECTORS DID NOT FIND THE FM ON NEEDLE HUB, AND IT CAUSED THE COMPLAINT CASE. THE FM ON NEEDLE HUB WAS OCCURRED IN THE NEEDLE HUB INJECTION PROCESS BY THE NEEDLE SUPPLIER. THE COMPLAINT NEEDLE WAS SUPPLIED INTO 10ML SYRINGE ASSEMBLY PROCESS, AT THAT TIME THE NEEDLE IS COVERED BY OPAQUE COLOR NEEDLE COVER, BUT THE COLOR OF COVER IS NOT AFFECTED TO INSPECT THE FM. THEREFORE, IT CAUSED THIS COMPLAINT CASE. CORRECTIVE ACTIONS: 1. QUALITY TRAINING ON THIS CUSTOMER COMPLAINT FOR SYRINGE ASSEMBLY LINE WORKERS AND QUALITY INSPECTORS. 2. TIGHTENING INCOMING INSPECTION FOR BULK NEEDLES AND KEEP MONITORING OF SYRINGE MANUFACTURING PROCESS TO PREVENT RECURRENCE OF THE SAME CASE. 3. IMPLEMENTING 100% VISUAL INSPECTION ON SYRINGE PACKAGING PROCESS AND HAD RETRAINED ON INSPECTION METHOD FOR PACKAGING INSPECTOR DUE TO THIS COMPLAINT CASE EFFECTIVE. CONCLUSION: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1101213. BASED ON IR ANALYSIS OF THE COMPLAINT SAMPLE, THE FM IS SAME MATERIAL WITH NEEDLE HUB. CURRENTLY, SBDM CONDUCT 100% VISUAL INSPECTION IN ASSEMBLY AND PACKING ON THE ASSEMBLY PROCESS. IT IS ASSUME THAT THE INSPECTORS DID NOT FIND THE FM ON NEEDLE HUB, AND IT CAUSED THE COMPLAINT CASE. THE FM ON NEEDLE HUB WAS OCCURRED IN THE NEEDLE HUB INJECTION PROCESS BY THE NEEDLE SUPPLIER. THE COMPLAINT NEEDLE WAS SUPPLIED INTO 10ML SYRINGE ASSEMBLY PROCESS, AT THAT TIME THE NEEDLE IS COVERED BY OPAQUE COLOR NEEDLE COVER, BUT THE COLOR OF COVER IS NOT AFFECTED TO INSPECT THE FM. THEREFORE, IT CAUSED THIS COMPLAINT CASE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS FOUND ON THE SYRINGE 10ML 21G 1-1/4IN NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE FOREIGN MATERIALS ON THE NEEDLE HUB (BLACK DOTS)"

    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. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 BLACK FOREIGN MATTER WAS FOUND ON THE SYRINGE 10ML 21G 1-1/4IN NEEDLE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE ARE FOREIGN MATERIALS ON THE NEEDLE HUB (BLACK DOTS)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915584 SYRINGE 10ML 21G 1-1/4IN PISTON SYRINGE FMF BECTON DICKINSON 1101213

    Patients

    Seq Age Sex Outcome Treatment
    1