BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32G 4MM XTW 5B 14PACK CHINA

    MDR report key: 11298473 · Received February 8, 2021

    Report

    Report Number
    3006948883-2021-00201
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 18, 2021
    Report Date
    May 7, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION: NO ACTUAL DEFECT SAMPLE RETURNED, SO A COMPREHENSIVE EVALUATION AND INVESTIGATION CANNOT BE CONDUCTED. APPEARANCE CHECK AND CLOG TEST WAS CONDUCTED ON 7PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG FAIL FOUND. LOT# 0042811 DHR AND RELATED MANUFACTURING RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    CORRECTION H6: IMDRF ANNEX B: B01. H6: IMDRF ANNEX C: C070603. THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-06. H6: INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NEEDLE 32G 4MM XTW 5B 14PACK CHINA WAS DAMAGED AND UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ON (B)(6) 2021, THE REP VISITED CUSTOMER. THE CUSTOMER RESPONDED THAT THE NEEDLE DID NOT FLOW FLUID , THIS WAS REPORTED BY A PATIENT . SHE CHECKED THE PEN NEEDLE AND FOUND THAT THERE WAS NO TIP OF THE PEN NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NEEDLE 32G 4MM XTW 5B 14PACK CHINA WAS DAMAGED AND UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ON JANUARY 18, 2021, THE REP VISITED CUSTOMER. THE CUSTOMER RESPONDED THAT THE NEEDLE DID NOT FLOW FLUID , THIS WAS REPORTED BY A PATIENT . SHE CHECKED THE PEN NEEDLE AND FOUND THAT THERE WAS NO TIP OF THE PEN NEEDLE"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NEEDLE 32G 4MM XTW 5B 14PACK CHINA WAS DAMAGED AND UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "ON (B)(6) 2021, THE REP VISITED CUSTOMER. THE CUSTOMER RESPONDED THAT THE NEEDLE DID NOT FLOW FLUID , THIS WAS REPORTED BY A PATIENT . SHE CHECKED THE PEN NEEDLE AND FOUND THAT THERE WAS NO TIP OF THE PEN NEEDLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187743 PEN NEEDLE 32G 4MM XTW 5B 14PACK CHINA HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 0042811

    Patients

    Seq Age Sex Outcome Treatment
    1