BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION

    MDR report key: 6853683 · Received September 8, 2017

    Report

    Report Number
    3002682307-2017-00033
    Event Type
    Injury
    Date Received
    September 8, 2017
    Date of Event
    June 7, 2017
    Report Date
    October 2, 2017
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    K100209
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: RETAIN SAMPLE EVALUATION: WE HAVE EVALUATED (B)(4) UNITS WE KEEP AS RETAINED SAMPLES WITHOUT OBSERVING ANY DAMAGED SAFETY SHIELD OR ISSUE. ACTIVATION TEST WAS CONDUCTED WITHIN SPEC (AVERAGE 0,76 LB WHICH IS LOWER THAN 2,5)." "LOT NUMBER / PRODUCT FAMILY HISTORY" COMPLAINT TRENDING REVIEW OF THIS LOT FOR THIS ISSUE REVEALS NO MORE COMPLAINTS. "DHR/BHR REVIEW" "OUR PRODUCTION AND INSPECTION RECORDS AND HAVE ESTABLISHED THAT ALL PRODUCTION AND QUALITY PROCESSES WERE CARRIED OUT NORMALLY. NO NCMR'S. NEEDLES WERE PACKED IN MACHINE (B)(4) (SEPTEMBER 11-13RD, 2015) DURING WHICH 51 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. NEEDLES (#5246389) WERE ASSEMBLED IN MACHINES (B)(4) (SEPTEMBER 6-12ND, 2015) DURING WHICH 261 VISUAL INSPECTIONS WERE CARRIED OUT WITH ZERO DEFECTS NOTED. RESEARCH HAS NOT FOUND NO ISSUES OR ABNORMALITIES DURING MANUFACTURING OF INJECTED HUB BATCHES #5174421, #5198300, #5247173 AND #52205013, IN MACHINE N¿3567 (JUNE-SEPTEMBER 2015). 1 QN (#(B)(4)) OF COLOR VARIATION (INJECTED HUB BATCH #5183326) WAS DETECTED WHICH WOULD NOT AFFECT WHETHER OR NOT THE CONNECTION ISSUE; 1 QN (#(B)(4) OF FLASH IN RAMP (INJECTED HUB BATCH #5212244), 1 QN (#7091) OF BROKEN RAMP (INJECTED HUB BATCH #5191364), 1 QN (#(B)(4)) OF BENT RAMP WERE DETECTED WHICH WOULD NOT AFFECT WHETHER OR NOT THE REPORTED ISSUE. RESEARCH HAS NOT FOUND NO ISSUES OR ABNORMALITIES DURING MANUFACTURING OF INJECTED SAFETY SHIELD BATCHES #5240445 AND #5246491 IN MACHINES N¿3586-3571 (SEPTEMBER 2015). 3 QN (#(B)(4)) OF FLASH AT GATE WERE REACHED (INJECTED SAFETY SHIELD BATCH #5252128 AND #5247190) WHICH WOULD NOT AFFECT THE REPORTED ISSUE. FUNCTIONAL TESTS BEFORE RELEASE: ENGAGEMENT FORCE: CPU 1,47, CPL 1,12 (BOTH HIGHER THAN SPEC 0,80). SAFETY SHIELD ACTIVATION: AVERAGE 0,81LB, MAX VALUE 0,96LB (LOWER THAN 2,5LB)." BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE CUSTOMER COMPLAINT ABOUT DEFECTIVE SAFETY SHIELD; NOT POSSIBLE TO CONFIRM WITH AVAILABLE INFORMATION AND WITHOUT AFFECTED SAMPLE OR PICTURE. ROOT CAUSE: "FIRST OF ALL, WE WOULD LIKE TO INFORM YOU OUR ASSEMBLY PROCESS HAS A SYSTEM THAT INSPECTS 100% THE PROPERLY OPENING AND ACTIVATION OF SAFETY SHIELD (PINK SHIELD) OF NEEDLES, REJECTING THE DEFECTIVE ONES. IN ADDITION, AT THE BEGINNING OF EVERY SHIFT, OPERATORS CHALLENGE THE DETECTION VERIFYING IT WORKS PROPERLY. SINCE WE WERE NOT PROVIDED WITH AFFECTED SAMPLE, DHR REVIEW SHOW NO ABNORMALITIES, AND FUNCTIONAL TEST OF RETAINED SAMPLES OF REPORTED LOT WAS FOUND WITHIN SPECIFICATIONS, AN ABSOLUTE ROOT CAUSE RELATED TO NEEDLE MANUFACTURING PROCESS FOR THIS INCIDENT CANNOT BE DETERMINED AT THIS TIME. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED. ON THE OTHER HAND, TAKING INTO ACCOUNT USED PROCEDURE WAS NOT THE RECOMMENDED ONE IN OUR INSTRUCTIONS FOR USE ("WHICH USUALLY DOES NOT HAPPEN, BECAUSE THE NEEDLES DO NOT DISENGAGE FROM THE SYRINGE AND THEN SAFETY SHIELD IS CLOSE DIRECTLY WITH THE SUPPORT OF THE SYRINGE ON THE TRAY AND NOT WITH THE HAND"), HANDLING OF THE PRODUCT COULD HAVE SOME IMPLICATION ON THE ISSUE SINCE SAFETY SHIELD WAS NOT PROPERLY ACTIVATED BEFORE THROW IT AWAY." CAPA DETERMINATION RESULTS" NO - BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE, SINCE DEFECT WAS NOT CONFIRMED AND ROOT CAUSE SEEMS TO BE RELATED WITH AN INCORRECT HANDLING, IT WAS DETERMINATE THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. CID #(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE PRICKED HER FINGER AFTER ENGAGING THE SAFETY ON A 21 G X 1 1/2 IN. BD ECLIPSE" NEEDLE WITH SLIP TIP HUB CONFIGURATION. THE SAFETY SHIELD DID NOT FULLY COVER THE NEEDLE. MEDICAL INTERVENTION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633733 21 G X 1 1/2 IN. BD ECLIPSE¿ NEEDLE WITH SLIP TIP HUB CONFIGURATION SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 1509007

    Patients

    Seq Age Sex Outcome Treatment
    1 Other