BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER

    MDR report key: 8735995 · Received June 26, 2019

    Report

    Report Number
    1024879-2019-01071
    Event Type
    Malfunction
    Date Received
    June 26, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 2, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903686563
    PMA / PMN Number
    K011984
    Removal / Correction Number
    PAS-19-1567
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. ADDITIONAL INFORMATION: THIS INFORMATION IS ASSOCIATED WITH FIELD ACTION # 2243072-07/22/2019-009-R. RECALL SUMMARY: BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR CERTAIN LOTS OF BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, CATALOG# 368656. BD HAS CONFIRMED THAT THESE LOTS MAY EXHIBIT SEPARATION OF FRONT AND REAR BARRELS UPON ACTIVATION OF THE SAFETY FEATURE THAT RETRACTS THE NEEDLE. PRODUCT AND SCOPE: BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER, CATALOG NUMBER 368356, FOR THE FOLLOWING 12 LOTS: 9079767, 9079770, 9081829, 9086811, 9086812, 9091607, 9091626, 9094659, 9094661, 9098547, 9100711, 9100712. LOTS NOT INCLUDED IN THE SCOPE OF THE RECALL ARE NOT AFFECTED. DESCRIPTION OF ISSUE: BD HAS CONFIRMED THAT THESE LOTS MAY EXHIBIT SEPARATION OF FRONT AND REAR BARRELS UPON ACTIVATION OF THE SAFETY FEATURE THAT RETRACTS THE NEEDLE. BARREL SEPARATION MAY RESULT IN LEAKAGE OF BLOOD OR AN EXPOSED NEEDLE, POTENTIALLY RESULTING IN EXPOSURE TO BLOOD BORNE PATHOGENS. BD PAS IDENTIFIED THIS ISSUE THRU THE BD COMPLAINT INVESTIGATION SYSTEM. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE: PER 806 # 2243072-07/22/2019-009-R DATED AUGUST 2, 2019, THERE WERE A TOTAL OF 33 COMPLAINTS AND 31 MDRS WITHIN SCOPE. COMPLAINT: (B)(4), MDR:1024879-2019-00960; (B)(4), 1024879-2019-00981; (B)(4), 1024879-2019-00975; (B)(4), 1024879-2019-00991; (B)(4), 1024879-2019-01005; (B)(4), 1024879-2019-00984; (B)(4), 1024879-2019-01038; (B)(4), 1024879-2019-01059; (B)(4), 1024879-2019-01071; (B)(4), 1024879-2019-01064; (B)(4), 1024879-2019-01094; (B)(4), 1024879-2019-01076; (B)(4), 1024879-2019-01107; (B)(4), 1024879-2019-01107; (B)(4), 1024879-2019-01091; (B)(4), 1024879-2019-01143; (B)(4), 1024879-2019-01130; (B)(4), 1024879-2019-01147; (B)(4), 1024879-2019-01157; (B)(4), 1024879-2019-01156; (B)(4), 1024879-2019-01163; (B)(4), 1024879-2019-01237; (B)(4), 1024879-2019-01195; (B)(4), 1024879-2019-01218; (B)(4), 1024879-2019-01116; (B)(4), 1024879-2019-01224; (B)(4), 1024879-2019-01197; (B)(4), 1024879-2019-01273; (B)(4), 1024879-2019-01304; (B)(4), 1024879-2019-01265; (B)(4), 1024879-2019-01303; (B)(4), 1024879-2019-01288; (B)(4), 1024879-2019-01288. HHE SUMMARY: THE HHE CONSIDERED THE POTENTIAL HAZARDS, HARMS, SEVERITIES, AND LIKELIHOOD OF OCCURRENCE RELATED TO THE PRODUCT, SPECIFICALLY THE REPORTED ISSUE REGARDING THE SAFETY MECHANISM NOT FUNCTIONING AS INTENDED. EXPOSURE TO BLOOD, INCLUDING BLOODBORNE PATHOGENS REPRESENTS A POTENTIAL FOR IMMEDIATE AND LONG-TERM HEALTH CONSEQUENCE TO THE HEALTHCARE WORKER. THIS WOULD BE IN THE PRESENCE OF A NEEDLESTICK INJURY TO THE HCW AFTER THE DEVICE WAS USED ON A PATIENT AS WELL AS BLOOD LEAKAGE FROM THE DEVICE WHICH COULD COME IN DIRECT CONTACT WITH THE UNPROTECTED SKIN (NOT FOLLOWING PROPER PPE PROCEDURE) OF THE HCW COLLECTING THE BLOOD. THE LIKELIHOOD OF HEALTH RISK FROM THE USAGE OF UNNECESSARY POST-EXPOSURE PROPHYLAXIS (PEP) AND LABORATORY TESTING DUE TO CONTAMINATED NEEDLE STICK INJURY OR EXPOSURE OF NON-INTACT SKIN IS CONSIDERED MINIMAL. THIS IS SUPPORTED BY DOCUMENTED LITERATURE THAT INDICATES GOOD EFFICACY OF PEP BEING OBSERVED WITH NO SEROCONVERSION. GENERAL AWARENESS FOR THE USE OF SHARPS AS WELL AS THE USE OF GENERAL SAFETY PRECAUTIONS IS KNOWN TO HELP DECREASE THE LIKELIHOOD OF EXPOSURE TO BLOODBORNE PATHOGENS. INVESTIGATION SUMMARY: ROOT CAUSE INVESTIGATION INDICATES A MIS-ALIGNMENT OF TOOLING TO LOAD AND ASSEMBLE COMPONENTS IN THE ASSEMBLY LINE. BD PAS HAS INITIATED CAPA 982194 TO FURTHER INVESTIGATE THIS ISSUE, AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z# PLEASE REFERENCE BD RECALL # PAS-19-1567.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SEPARATION OF THE FRONT AND REAR BARREL COMPONENTS WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SEPARATION OF THE FRONT AND REAR BARREL COMPONENTS WITH THE INCIDENT LOT WAS OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: A CAPA HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. CAPA #982194. BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    MATERIAL NO. 368656, BATCH NO. 9079767. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THE SAFETY SHIELD DID NOT ENGAGE. THE BODY OF WINGSET CAME APART BREAKING OFF FROM THE TUBING LEAVING THE NEEDLE FULLY EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A BUTTERFLY NEEDLE REF NUMBER 368656, LOT # 9079767 THAT WHEN THE GIRL WENT TO ENGAGE THE SAFETY SHIELD BY PRESSING THE BUTTON, THE WHOLE BLUE WINGED AREA BROKE COMPLETELY OFF FROM THE TUBING LEAVING THE NEEDLE FULLY EXPOSED. I HAVE THE DEVICE ON MY DESK.

    Description of Event or Problem · 0

    MATERIAL NO. 368656. BATCH NO. 9079767. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THE SAFETY SHIELD DID NOT ENGAGE. THE BODY OF WINGSET CAME APART BREAKING OFF FROM THE TUBING LEAVING THE NEEDLE FULLY EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A BUTTERFLY NEEDLE REF NUMBER 368656, LOT # 9079767, THAT WHEN THE GIRL WENT TO ENGAGE THE SAFETY SHIELD BY PRESSING THE BUTTON, THE WHOLE BLUE WINGED AREA BROKE COMPLETELY OFF FROM THE TUBING LEAVING THE NEEDLE FULLY EXPOSED. I HAVE THE DEVICE ON MY DESK.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.

    Description of Event or Problem · 1

    MATERIAL NO. 368656, BATCH NO. 9079767. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER THE SAFETY SHIELD DID NOT ENGAGE. THE BODY OF WINGSET CAME APART BREAKING OFF FROM THE TUBING LEAVING THE NEEDLE FULLY EXPOSED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE A BUTTERFLY NEEDLE REF NUMBER 368656 LOT # 9079767 THAT WHEN THE GIRL WENT TO ENGAGE THE SAFETY SHIELD BY PRESSING THE BUTTON, THE WHOLE BLUE WINGED AREA BROKE COMPLETELY OFF FROM THE TUBING LEAVING THE NEEDLE FULLY EXPOSED. I HAVE THE DEVICE ON MY DESK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531365 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9079767 50382903686563

    Patients

    Seq Age Sex Outcome Treatment
    1 Other