BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SAFETY NEEDLE

    MDR report key: 3924760 · Received June 20, 2014

    Report

    Report Number
    1017768-2014-00016
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Report Date
    April 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) FOR LOTS 334351X AND 400613X WERE REVIEWED AND NO ISSUES WERE FOUND WITH SAMPLES INSPECTED DURING THE PRODUCTION OF THE LOTS. THE DHR WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE PRODUCTION OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. A REVIEW OF MAINTENANCE RECORDS (BOTH CORRECTIVE AND PREVENTIVE) AND CALIBRATION RECORDS WERE REVIEWED AND THERE WERE NO ISSUES. ALL SCHEDULED MAINTENANCE AND CALIBRATION ACTIVITIES WERE COMPLETED ON TIME. THERE WAS NO RELATED PROCESS OR MATERIAL CHANGES RELATED TO THIS TYPE OF ISSUE FOR THIS PRODUCT WITHIN THE PREVIOUS 12 MONTHS. A REVIEW OF THE MACHINE SETUP WAS CONDUCTED AND THERE WERE NO ISSUES NOTED. OBSERVATION OF THE MACHINE AT ITS CURRENT CONDITION DOES NOT REVEAL ANY ISSUES. THERE WERE (B)(4) UNOPENED SAMPLES RETURNED WITH THIS COMPLAINT. THE ACTUAL SAMPLE INVOLVED IN THIS INCIDENT WAS NOT RETURNED. THE CUSTOMER REPORTED THAT THE SAMPLE WAS A MAGELLAN SAFETY NEEDLE FROM LOT 331576X. HOWEVER, THE CUSTOMER RETURNED SAMPLES OF MAGELLAN SAFETY NEEDLES FROM LOT 400613X. ALSO, THE CUSTOMER PROVIDED THREE (3) PICTURES WITH THIS COMPLAINT. THE PICTURES SHOWED THAT THE TIP OF THE CANNULA WAS BENT ALMOST 45 DEGREES TO THE OPPOSITE SIDE WHERE THE THUMB REST IS TO ACTIVATE THE SAFETY SHIELD. AN INVESTIGATION WAS CONDUCTED ON THE SAMPLES PROVIDED FOR EVALUATION. VISUAL EXAMINATION UNDER 7X MAGNIFICATION LOUPE WAS PERFORMED BY THE QUALITY ENGINEER FOR THE MOLDING ISSUE THAT COULD PREVENT THE SHIELD TO PERFORM AS INTENDED. ALSO, THE SAMPLES WERE PHYSICALLY MANIPULATED TO ENSURE PROPER FUNCTIONALITY.

    Description of Event or Problem · 1

    IT WS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SAFETY SYRINGE THE CUSTOMER REPORTS A MALFUNCTION ENGAGING THE SAFETY DEVICE. THE CUSTOMER REPORTS A MALFUNCTION ENGAGING THE SAFETY DEVICE. THE CUSTOMER REPORTED THEY ARE USING IT ON CHILDREN WHO HAD MORE TENSE MUSCLES AND THE NEEDLES WOULD BEND UPON USE. WHEN THEY WOULD THEN GO TO ACTIVATE THE SAFETY SHIELD IT WOULD SLIDE BACK DOWN.

    Description of Event or Problem · 1

    THE SHIELDS FOR ALL (B)(4) SAMPLES WERE ACTIVATED SUCCESSFULLY DURING EVALUATION. NO ISSUES WERE FOUND. THE QUALITY ENGINEER ALSO PERFORMED A CHECK OF THE OUTSIDE DIAMETER (OD) OF ALL (B)(4) SAMPLES RETURNED BY THE CUSTOMER TO ENSURE THAT THE PROPER CANNULA SIZE WAS USED. THIS TEST WAS PERFORMED USING A MICROMETER. THE DIAMETERS OF ALL (B)(4) SAMPLES WERE WITHIN SPECIFICATION. THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED WITH THE SAMPLES PROVIDED. THE EXACT ROOT CAUSE OF THE ISSUE REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED WITHOUT AN ACTUAL SAMPLE TO EXAMINE. SINCE THE PICTURES SUBMITTED SHOWS THAT THE NEEDLE WAS BENT, IT IS DETERMINED THAT THE ROOT CAUSE OF THE SAFETY SHIELD NOT FUNCTIONING PROPERLY WAS THE BENT CANNULA. IT IS UNLIKELY THAT THIS BENDING WOULD OCCUR DURING THE MANUFACTURE PROCESS BECAUSE THE NEEDLE SHIELD AND SHEATH WOULD NOT LOAD ON A BENT CANNULA. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE RESULT OF THE SAMPLES EVALUATION IT IS LIKELY THAT THE NEEDLE WAS BENT DURING USE. PRIOR TO A LOTS 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. BASED ON THE EVALUATION OF THE SAMPLES, COMPLAINT TRENDING AND THE ISSUE NOT BEING CONFIRMED TO BE MANUFACTURING RELATED, A CORRECTIVE AND PREVENTATIVE ACTION WILL NOT BE PERFORMED AT THIS TIME. AS A REFERENCE, THE INSTRUCTION FOR USE UNDER STEP 6 AND 7 INDICATES: STEP 6. PERFORM INJECTION (OR ASPIRATION OF BODY FLUID) ACCORDING TO LOCAL STANDARD PROCEDURE AND ASEPTIC TECHNIQUE: STEP 7. IMMEDIATELY FOLLOWING THE INJECTION OR ASPIRATION PROCEDURE, LOCK THE SAFETY NEEDLE SHIELD USING ANY OF THE FOLLOWING METHOD: PUSH THE SAFETY SHIELD FORWARD IN A SINGLE-HANDED MANNER TO COVER THE NEEDLE AND LOCK THE SHIELD. KEEP YOUR FINGER OR THUMB BEHIND THE NEEDLE TIP AT ALL TIMES. OR PRESS THE SAFETY SHIELD, LEVER SIDE DOWN ONTO A FLAT SURFACE TO COVER THE NEEDLE AND LOCK THE SHIELD, I.E., BEDSIDE TABLE. THIS INFORMATION WILL BE UTILIZED FOR TRENDING PURPOSES TO DETERMINE THE NEED FOR CORRECTIVE ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362574 UNKNOWN SAFETY NEEDLE SAFETY NEEDLE FMF COVIDIEN UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK