BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 32G X 4MM 3B TW

    MDR report key: 12206859 · Received July 21, 2021

    Report

    Report Number
    3014704491-2021-00045
    Event Type
    Malfunction
    Date Received
    July 21, 2021
    Date of Event
    June 25, 2021
    Report Date
    July 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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: 2021-07-27. D4: MEDICAL DEVICE LOT #: 0184470. D4: MEDICAL DEVICE EXPIRATION DATE: 2025-07-31. H4: DEVICE MANUFACTURE DATE: 2020-11-03. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (4) SEALED 32GX4MM PEN NEEDLES FROM LOT# 0184470. THE CONSUMER REPORTED THAT THE PATIENT END IS SHORTER THAN WHAT SHE REMEMBERS. ALL 4 RETURNED PEN NEEDLES WERE TESTED TO DETERMINE PATIENT END CANNULA LENGTH (SPECS FOR 4MM CANNULA LENGTH: 0.109¿-0.203¿), AND THE FOLLOWING WAS OBSERVED: DATA: PE CANNULA LENGTH (INCHES): SAMPLE 1: 0.164; SAMPLE 2: 0.162; SAMPLE 3: 0.158; SAMPLE 4: 0.163. ALL 4 PEN NEEDLES MEASURED WITHIN SPECIFICATION. NO DEFECTS WERE OBSERVED. DHR WAS REVIEWED FOR LOTS #0136694 AND #0184470 AND NO QN FOUND. 7PCS RETENTIONS TESTED THE LENGTH OF IV POINT; ALL PRODUCTS MEET THE SPECIFICATION. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE HENCE THE ROOT CAUSE IS UNDETERMINED. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PN RELION 32G X 4MM 3B TW CANNULA WAS TOO SHORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSUMER REPORTED THAT THE PATIENT END OF THE NEEDLE IS SHORTER THAN WHAT SHE REMEMBERS. DATE OF EVENT: UNKNOWN. SAMPLES: YES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING 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 1 PN RELION 32G X 4MM 3B TW CANNULA WAS TOO SHORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CONSUMER REPORTED THAT THE PATIENT END OF THE NEEDLE IS SHORTER THAN WHAT SHE REMEMBERS. DATE OF EVENT: UNKNOWN; SAMPLES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099770 PN RELION 32G X 4MM 3B TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1