BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREVENT NEEDLE ONLY 25 X 5/8

    MDR report key: 10453990 · Received August 26, 2020

    Report

    Report Number
    1017768-2020-00842
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Report Date
    March 4, 2022
    Manufacturer
    COVIDIEN
    Product Code
    FMI
    UDI-DI
    10612479201351
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR LOT 003416 WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. THREE UNUSED-OPENED SAMPLES AND FOUR PHOTOS WERE RETURNED FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE VISUALLY INSPECTED, AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. THE INVESTIGATION ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURING PROCESS THAT WOULD HAVE CAUSED THE ISSUE FOR THIS LOT; THEREFORE, THIS IS CONSIDERED AN ISOLATED INCIDENT. A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY AT THIS TIME. SECTION D1 (BRAND NAME): INITIALLY REPORTED AS NEEDLE DENTAL 27G LONG AND SHOULD HAVE BEEN REPORTED AS PREVENT NEEDLE ONLY 25 X 5/8. SECTION D2A (PRODUCT CODE): INITIALLY REPORTED AS DZM AND SHOULD HAVE BEEN REPORTED AS SECTION D2B (COMMON DEVICE NAME): INITIALLY REPORTED AS NEEDLE, DENTAL AND SHOULD HAVE BEEN REPORTED AS NEEDLE, HYPODERMIC, SINGLE LUMEN. SECTION D4 (LOT NUMBER): INITIALLY REPORTED AS 007624 AND SHOULD HAVE BEEN REPORTED AS 003416.

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY THE PROVIDED LOT NUMBER PERTAINS TO A DIFFERENT PRODUCT ID THAN REPORTED. THE REPORTED ITEM IS A 27G LONG DENTAL NEEDLE AND DOES NOT CORRESPOND TO THE LOT NUMBER GIVEN. THE DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED FOR THE SAMPLE RETURNED FOR THE COMPLAINT. THE DHR FOR THE REPORTED LOT SHOWS NO ISSUES WERE FOUND IN VISUAL OR PHYSICAL SAMPLES INSPECTED FOR THAT LOT NUMBER. THERE WAS ONE OPENED NEEDLE SUBMITTED FOR EVALUATION. THE SAMPLE WAS VISUALLY INSPECTED, AND IT WAS NOTICED THAT THE NEEDLE IS NOT FROM THIS FACILITY. THE DESIGN OF THE SHEATH IS DIFFERENT FROM THE ONES MOLDED IN THIS FACILITY. THE RIBS OF THE SHEATH ARE COMPLETELY DIFFERENT, AND THE FINISHING OF THE MOLDED COMPONENT IS DIFFERENT. ADDITIONALLY, THE NEEDLE IS NOT A DENTAL NEEDLE AS STATED IN THE COMPLAINT, NOR A SAFETY NEEDLE AS THE DHR FOR THE REPORTED LOT INDICATES. ADDITIONALLY, THE HUB OF THIS NEEDLE HAS A COMPLETELY DIFFERENT DESIGN AS THE HUBS MOLDED AT OUR SITE. THE REPORTED CONDITION OF MATERIAL INSIDE THE SHEATH OR ON THE NEEDLE IS NOT CONFIRMED BASED ON THE SAMPLE ANALYSIS. THE EXACT ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. THE INVESTIGATION ANALYSIS DID NOT IDENTIFY ANY ISSUES WITH THE MANUFACTURING PROCESS THAT WOULD HAVE CAUSED THE REPORTED ISSUE. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. SPECIFICALLY, SAMPLES ARE INSPECTED FOR POOR WORKMANSHIP, CONTAMINATION, AND INCORRECT ASSEMBLY. THE LOT MET ALL DEFINED ACCEPTANCE REQUIREMENTS AND WAS RELEASED. THERE¿S NO INDICATION OF A SYSTEMIC ISSUE WITH THE PRODUCT OR PROCESS, SO A CORRECTIVE AND PREVENTATIVE ACTION (CAPA) WILL NOT BE ISSUED AT THIS TIME. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    Additional Manufacturer Narrative · 1

    THE INCIDENT SAMPLE HAS BEEN REQUESTED BUT TO DATE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED, OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER REPORTS: THE NEEDLES HAVE PLASTIC PARTICLES INSIDE THE NEEDLE SHEATH AS WELL AS ON THE NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918665 PREVENT NEEDLE ONLY 25 X 5/8 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 26558 003416 10612479201351
    918666 PREVENT NEEDLE ONLY 25 X 5/8 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI COVIDIEN 26558 003416 10612479201351

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown