BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYPOINT NDL27GA1/2IN

    MDR report key: 10049897 · Received May 12, 2020

    Report

    Report Number
    8041187-2020-00257
    Event Type
    Injury
    Date Received
    May 12, 2020
    Date of Event
    April 17, 2020
    Report Date
    May 6, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903002559
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9071971. MEDICAL DEVICE EXPIRATION DATE: 2024-03-30. DEVICE MANUFACTURE DATE: 2019-05-14. MEDICAL DEVICE LOT #: 9071970. MEDICAL DEVICE EXPIRATION DATE: 2024-03-30. DEVICE MANUFACTURE DATE: 2019-05-14. INVESTIGATION SUMMARY: NO RETURNED SAMPLE WAS RECEIVED. 2 RETURNED PHOTO WAS RECEIVED. IT IS UNCLEAR WHERE IS THE BROKEN NEEDLE. DHR REVIEWED FOR AFFECTED BATCH NUMBERS FOR HYPOINT NEEDLE, HYPODERMIC NEEDLE, CANNULA DO NOT OBSERVE ABNORMALITIES RELATED TO BROKEN NEEDLE. INVESTIGATION CONCLUSION: FROM THE PHOTOS, IT IS UNCLEAR HOW THE NEEDLE IS BROKEN. UNABLE TO CONFIRM THE CUSTOMER EXPERIENCE BASED ON PHOTO EVALUATION. ROOT CAUSE DESCRIPTION: ROOT CAUSE COULD NOT BE ESTABLISHED. RATIONALE: THE COMPLAINT WILL BE RE-OPENED ONCE COMPLAINT SAMPLE IS RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HYPOINT NDL27GA1/2IN NEEDLE BROKE DURING INJECTION. THIS COULD LEAD TO PATIENT INJURY OR THE PATIENT NOT RECEIVING REQUIRED DOSE ON TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BROKEN NEEDLE TIP. A HOSPITAL PHARMACIST REPORTED THAT A PATIENT BROUGHT A DEFECTIVE PRODUCT AND ASKED FOR REPLACEMENT. THE PHARMACIST SAID THIS PRODUCT WAS SOLD TO THE PATIENT BY THE HOSPITAL. WHEN THE PATIENT CAME TO THE HOSPITAL, THE PATIENT CLAIMED THE NEEDLE WAS BROKEN WHILE PERFORMING INJECTION BY HIMSELF. THEN, THE PATIENT CHANGED A NEW NEEDLE (UNKNOWN SOURCE) AND PERFORMED INJECTION AGAIN. THE DETAILED INFORMATION REGARDING THE INJECTION PROCESS COULD NOT BE CONFIRMED. THE NEEDLE WAS BROKEN DURING INJECTION; THIS ISSUE COULD HAVE LED TO PATIENT INJURY OR THE PATIENT COULD NOT HAVE RECEIVED THE REQUIRED DOSE ON TIME. IT HAS A POTENTIAL RISK TO PATIENT SAFETY, SO AFFILIATE REPORTS THIS CASE AS A POTENTIAL CRITICAL COMPLAINT. A FULL INVESTIGATION IS REQUIRED FOR THIS COMPLAINT SINCE THE NURSE WAS INJURED. THIS COMPLAINT IS CONSIDERED POTENTIAL CRITICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509677 HYPOINT NDL27GA1/2IN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 300255 SEE H.10 00382903002559

    Patients

    Seq Age Sex Outcome Treatment
    1 Other