BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8417509 · Received March 13, 2019

    Report

    Report Number
    2243072-2019-00476
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    February 22, 2019
    Report Date
    June 25, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MEDICAL DEVICE BRAND NAME: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. MEDICAL DEVICE TYPE: FMI. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD). CATALOG #: 368607. UNIQUE IDENTIFIER (UDI) #: (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8047731. MEDICAL DEVICE EXPIRATION DATE: 2/28/2023. DEVICE MANUFACTURE DATE: 2/16/2018. MEDICAL DEVICE LOT #: 7181805. MEDICAL DEVICE EXPIRATION DATE: 6/30/2022. DEVICE MANUFACTURE DATE: 6/30/2017. MANUFACTURING LOCATION: BECTON, DICKINSON & CO., (BD). PMA/510(K) #: K982541. INVESTIGATION SUMMARY: BD RECEIVED A TOTAL OF FIFTY-TWO (52) SAMPLES FROM THE CUSTOMER CONSISTING OF: (B)(4) SAMPLES FROM LOT 8047731 OF WHICH (B)(4) HAD TORN UNIT LABELS AND ASSUMED TO HAVE BEEN PREVIOUSLY OPENED; (B)(4) SAMPLES FROM LOT 7181805 WITH TORN UNIT LABELS AND ASSUMED TO HAVE BEEN PREVIOUSLY OPENED; AND (B)(4) SAMPLES THAT WERE MISSING THE NON-PATIENT SHIELD AND THEREFORE THE BATCH NUMBER COULD NOT BE IDENTIFIED. THESE SAMPLES WERE ASSUMED TO HAVE BEEN PREVIOUSLY OPENED. BELOW IS THE SUMMARY OF INVESTIGATION THAT WAS PERFORMED: VISUAL INSPECTION WAS CONDUCTED ON ALL SAMPLES RECEIVED UNDER MAGNIFICATION. THREE (3) SAMPLES (1 FROM LOT 8047731 AND 2 FROM THE UNKNOWN LOT) EXHIBITED SOME DEGREE OF POINT DAMAGE. HOWEVER, AS THE THREE (3) SAMPLES ARE ASSUMED TO HAVE BEEN OPENED, IT COULD NOT BE CONCLUDED HOW THE POINT DAMAGE OCCURRED. THE REST OF THE SAMPLES DID NOT SHOW ANY ISSUE RELATED TO POINT DAMAGE. PENETRATION FORCE TESTING WAS CONDUCTED ON UNOPENED SAMPLES ONLY, AND ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ADDITIONAL INSPECTION AND TESTING WERE PERFORMED ON RETENTION SAMPLES FROM THE KNOWN INCIDENT LOTS 7181805 AND 8047731 AND ALL SAMPLES MET THE REQUIRED SPECIFICATIONS. ADDITIONALLY, BD RECEIVED NINETY-SEVEN (97) PHOTOS. THE BATCH NUMBER COULD NOT BE DETERMINED AS ONLY A PORTION OF THE NEEDLE WAS VISIBLE FROM THE PHOTOS. UPON EVALUATION OF THE PHOTOS, IT WAS DETERMINED THAT THE SURFACE CONDITION OF THE NEEDLES APPEARS TO BE CONSISTENT WITH WHAT MAY OCCUR AS A RESULT OF A MANUFACTURING PROCESS STEP IN THE CANNULA MANUFACTURING. TWO (2) OF THE PHOTOS DID DISPLAY CANNULA WITH WHAT APPEARS TO BE DAMAGE TO THE IV POINT. THIS DEFECT, IF OBSERVED IN MANUFACTURING, WOULD VERY LIKELY BE IDENTIFIED BY THE VISION SYSTEMS IN PRODUCTION AND PRODUCT WOULD BE REJECTED. THE POINT INSPECT VISION SYSTEM CONDUCTS AN AUTOMATED 100% INSPECTION ON ALL PRODUCTS AND IS CAPABLE OF IDENTIFYING AND REJECTING CANNULA POINTS THAT DO NOT MEET OUR SPECIFICATIONS, PRIOR TO THE IV SHIELDING PROCESS. WE CHALLENGE THE POINT INSPECT VISION SYSTEM EVERY SHIFT WITH KNOWN ACCEPTABLE AND DEFECTIVE POINTS TO ASSURE ITS CONTINUED ACCURACY IN DETECTING DEFECTIVE UNITS. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE KNOWN INCIDENT LOTS AND NO ISSUES WERE IDENTIFIED RELATED TO POINT DAMAGE. BD IS REVIEWING SPECIFIC AREAS IN THE MANUFACTURING PROCESS WHERE POTENTIAL CAUSES OF THIS ISSUE MAY HAVE ORIGINATED. THE ASSESSMENT (INCLUDING VISUAL INSPECTION) PERFORMED BY BD ON THE UNOPENED SAMPLES DID NOT DEMONSTRATE NEEDLE POINT DAMAGE. FURTHERMORE, PENETRATION FORCE TESTING MET SPECIFICATIONS IMPLYING THERE IS NO CHANGE EXPECTED IN NEEDLE INSERTION FORCE DURING VENIPUNCTURE PRACTICE. BASED ON THESE FINDINGS THERE SEEMS TO BE NO INDICATION THAT THE BD ECLIPSE NEEDLES WERE A CONTRIBUTING FACTOR TO THE COMPLAINTS RELATED TO NERVE DAMAGE. REVIEW OF LITERATURE INDICATES THAT NERVES IN THE ANTECUBITAL FOSSA LIE IN A PLANE BENEATH AND IN CLOSE PROXIMITY OF THE VEINS MAKING THEM SUSCEPTIBLE TO INJURY DURING PHLEBOTOMY. NERVE DAMAGE IS USUALLY ASSOCIATED WITH POOR VENIPUNCTURE TECHNIQUE AND MAY RESULT AS A CONSEQUENCE OF EXCESSIVE BLIND OR LATERAL NEEDLE PROBING DURING DIFFICULT VENOUS ACCESS WHICH MAY IN TURN RESULT IN ACCIDENTALLY HITTING A NERVE IN THE VEIN VICINITY. ADDITIONALLY, IT HAS BEEN SHOWN THAT THERE IS LARGE VARIATION IN LOCATION OF VEINS AND NERVES IN THE ANTECUBITAL FOSSA WHICH SUGGESTS THAT NERVE DAMAGE MAY EVEN OCCUR IN NON-TRAUMATIC VENIPUNCTURES. [1-4] ALTHOUGH, A REVIEW OF THE COMPLAINT TRENDS DOES NOT INDICATE ANY OTHER COMPLAINTS SIMILAR IN NATURE BEING REPORTED, BD WILL CONTINUE TO MONITOR COMPLAINTS RECEIVED FOR THIS DEVICE AND THIS REPORTED CONDITION. BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. REFERENCES: OVEN SD, JOHNSON JD. RADIAL NERVE INJURY AFTER VENIPUNCTURE. J HAND MICROSURG 2017; 9:43-44. MCCALL R, TANKERSLEY C. PHLEBOTOMY ESSENTIALS. 6TH ED. PHILADELPHIA, PA: WOLTERS KLUWER;2016:281. RAMOS JA. VENIPUNCTURE-RELATED LATERAL ANTEBRACHIAL CUTANEOUS NERVE INJURY: WHAT TO KNOW? REV BRAS ANESTESIOL 2014;64:131-133. HOROWITZ SH. VENIPUNCTURE-INDUCED CAUSALGIA: ANATOMIC RELATIONS OF UPPER EXTREMITY SUPERFICIAL VEINS AND NERVES, AND CLINICAL CONSIDERATIONS. TRANSFUS 2000;40:1036-1040.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE THERE HAS BEEN AN INCREASED NERVE INJURIES RELATING TO DEFECTIVE NEEDLE TIPS WITH IRREGULARITIES IN THE SURFACE AND BURRS. THE NEEDLE BEVEL COULD BE CONTRIBUTING TO FALSELY ELEVATED POTASSIUM RESULTS. INCREASED NERVE INJURIES RELATING TO DEFECTIVE NEEDLE TIPS WITH IRREGULARITIES IN THE SURFACE AND BURRS. WE HAVE PHOTOGRAPHED A NUMBER OF DIFFERENT NEEDLES FROM DIFFERENT LOT NUMBERS AND MANY OF THESE SHOW A SIGNIFICANT DEFECT IN THE BACK END OF THE BEVEL WITH LOSS OF SURFACE COATING AND SOME BURRING ALONG THE OUTSIDE OF THE NEEDLE. WE ARE CONCERNED THAT AS THE NEEDLE IS PLACED IN THE ARM, THE BURRED EDGE COULD BE CATCHING ON NERVES THAT ARE ADJACENT TO THE VEIN. WE HAVE SEEN AN INCREASE IN PROBABLE NERVE INJURIES DESPITE CHANGING OUR SOP TO TRY TO PREVENT THESE. OVER THE LAST YEAR, WE HAVE SEEN APPROX. 20 OF THESE AND IN PREVIOUS YEARS, WE HAVE ONLY SEEN APPROX. 0.5 TO 1.0 PER MONTH. POSSIBILITY THAT THE IRREGULAR SURFACE OF THE NEEDLE BEVEL COULD BE CONTRIBUTING TO FALSELY ELEVATED POTASSIUM RESULTS. AS RED CELLS ARE PULLED OVER THE IRREGULAR SURFACE OF THE BACK END OF THE BEVELED PART OF THE NEEDLE, THEY ARE SHEERED CAUSING INCREASE IN POTASSIUM.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE "OF THE" THERE HAS BEEN AN INCREASED NERVE INJURIES RELATING TO DEFECTIVE NEEDLE TIPS WITH IRREGULARITIES IN THE SURFACE AND BURRS. THE NEEDLE BEVEL COULD BE CONTRIBUTING TO FALSELY ELEVATED POTASSIUM RESULTS. INCREASED NERVE INJURIES RELATING TO DEFECTIVE NEEDLE TIPS WITH IRREGULARITIES IN THE SURFACE AND BURRS. WE HAVE PHOTOGRAPHED A NUMBER OF DIFFERENT NEEDLES FROM DIFFERENT LOT NUMBERS AND MANY OF THESE SHOW A SIGNIFICANT DEFECT IN THE BACK END OF THE BEVEL WITH LOSS OF SURFACE COATING AND SOME BURRING ALONG THE OUTSIDE OF THE NEEDLE. WE ARE CONCERNED THAT AS THE NEEDLE IS PLACED IN THE ARM, THE BURRED EDGE COULD BE CATCHING ON NERVES THAT ARE ADJACENT TO THE VEIN. WE HAVE SEEN AN INCREASE IN PROBABLE NERVE INJURIES DESPITE CHANGING OUR SOP TO TRY TO PREVENT THESE. OVER THE LAST YEAR, WE HAVE SEEN APPROX. 20 OF THESE AND IN PREVIOUS YEARS, WE HAVE ONLY SEEN APPROX. 0.5 TO 1.0 PER MONTH. POSSIBILITY THAT THE IRREGULAR SURFACE OF THE NEEDLE BEVEL COULD BE CONTRIBUTING TO FALSELY ELEVATED POTASSIUM RESULTS. AS RED CELLS ARE PULLED OVER THE IRREGULAR SURFACE OF THE BACK END OF THE BEVELED PART OF THE NEEDLE, THEY ARE SHEERED CAUSING INCREASE IN POTASSIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211844 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other