BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 8544975 · Received April 24, 2019

    Report

    Report Number
    1917413-2019-01223
    Event Type
    Malfunction
    Date Received
    April 24, 2019
    Date of Event
    March 29, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    N/A
    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

    B.3. DATE OF EVENT: (B)(6) 2019.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: DESCRIPTION OF EVENT OR PROBLEM DESCRIBE EVENT OR PROBLEM: MATERIAL NO: 362753, BATCH NO: 8243890. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THE TUBES HAD POOR GEL SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO REPORT GEL ISSUE ON THE BD CPT LOT NO: 8243890 EXP 2019-09-30. TOTAL OF 3 TUBES WERE COLLECTED FROM THE PATIENT AND SENT WITHIN 24 HOURS. PLEASE COULD YOU PLEASE INVESTIGATE ON THE LOT AND PROVIDE US A DETAILED REPORT. WHAT SPECIFIC DATE DID THIS INCIDENT OCCUR? (B)(6)2019. CAN YOU PROVIDE THE REF OR PART NUMBER? BD CPT TUBE (SODIUM HEPARIN). WAS THERE ANY SERIOUS INJURY? THIS A CLINICAL TRIAL. WAS THERE ANY EXPOSURE TO BLOOD OR OTHER BODILY FLUID? NO. WERE THERE ANY ERRONEOUS RESULTS? IF SO, NO ANALYSIS. WHAT RESULTS WERE ABNORMAL. WHAT INSTRUMENT WAS USED. WHAT WAS THE CONDITION OF THE SAMPLE? WHAT IS YOUR COLLECTION METHOD? DUE TO THIS INCIDENT, WAS THERE A CHANGE IN COURSE OF TREATMENT? NO. WAS THERE NEED FOR A MEDICAL INTERVENTION? NO. WAS THERE ANY SAFETY ISSUES AT ALL? NO. WERE ANY OTHER ACTIONS TAKEN DUE TO THE INCIDENT? NO. ARE THERE SAMPLES AVAILABLE TO BE SENT BACK FOR THE INVESTIGATION? IF SO, LET US KNOW AND WE CAN SEND YOU A RETURN LABEL FOR YOUR CONVENIENCE. NO. IF PATIENT IDENTIFIERS ARE KNOWN, PLEASE PROVIDE A FEW SO WE CAN ACCURATELY CAPTURE THIS INFORMATION (GENDER, AGE, DOB, WEIGHT, ETC) NO. EVALUATION CODES INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION 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 CAPA#373360. 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 PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR BARRIER SEPARATION WITH THE INCIDENT WAS OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#373360 THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: CAPA#373360 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. RATIONALE: 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

    IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THE TUBES HAD POOR GEL SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO REPORT GEL ISSUE ON THE BD CPT LOT NO: 8243890 EXP 2019-09-30. TOTAL OF 3 TUBES WERE COLLECTED FROM THE PATIENT AND SENT WITHIN 24 HOURS. PLEASE COULD YOU PLEASE INVESTIGATE ON THE LOT AND PROVIDE US A DETAILED REPORT. WHAT SPECIFIC DATE DID THIS INCIDENT OCCUR? (B)(6) 2019. CAN YOU PROVIDE THE REF OR PART NUMBER? BD CPT TUBE (SODIUM HEPARIN). WAS THERE ANY SERIOUS INJURY? THIS A CLINICAL TRIAL. WAS THERE ANY EXPOSURE TO BLOOD OR OTHER BODILY FLUID? NO. WERE THERE ANY ERRONEOUS RESULTS? IF SO, NO ANALYSIS. WHAT RESULTS WERE ABNORMAL? WHAT INSTRUMENT WAS USED? WHAT WAS THE CONDITION OF THE SAMPLE? WHAT IS YOUR COLLECTION METHOD? DUE TO THIS INCIDENT, WAS THERE A CHANGE IN COURSE OF TREATMENT? NO. WAS THERE NEED FOR A MEDICAL INTERVENTION? NO. WAS THERE ANY SAFETY ISSUES AT ALL? NO. WERE ANY OTHER ACTIONS TAKEN DUE TO THE INCIDENT? NO. ARE THERE SAMPLES AVAILABLE TO BE SENT BACK FOR THE INVESTIGATION? IF SO, LET US KNOW AND WE CAN SEND YOU A RETURN LABEL FOR YOUR CONVENIENCE. NO. IF PATIENT IDENTIFIERS ARE KNOWN, PLEASE PROVIDE A FEW SO WE CAN ACCURATELY CAPTURE THIS INFORMATION (GENDER, AGE, DOB, WEIGHT, ETC) NO.

    Description of Event or Problem · 0

    MATERIAL NO: 362753, BATCH NO: 8243890. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THE TUBES HAD POOR GEL SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO REPORT GEL ISSUE ON THE BD CPT LOT NO: 8243890 EXP 2019-09-30. TOTAL OF 3 TUBES WERE COLLECTED FROM THE PATIENT AND SENT WITHIN 24 HOURS. PLEASE COULD YOU PLEASE INVESTIGATE ON THE LOT AND PROVIDE US A DETAILED REPORT. WHAT SPECIFIC DATE DID THIS INCIDENT OCCUR? (B)(6) 2019. CAN YOU PROVIDE THE REF OR PART NUMBER? BD CPT TUBE (SODIUM HEPARIN). WAS THERE ANY SERIOUS INJURY? THIS A CLINICAL TRIAL. WAS THERE ANY EXPOSURE TO BLOOD OR OTHER BODILY FLUID? NO. WERE THERE ANY ERRONEOUS RESULTS? IF SO, NO ANALYSIS. WHAT RESULTS WERE ABNORMAL. WHAT INSTRUMENT WAS USED. WHAT WAS THE CONDITION OF THE SAMPLE? WHAT IS YOUR COLLECTION METHOD? DUE TO THIS INCIDENT, WAS THERE A CHANGE IN COURSE OF TREATMENT? NO. WAS THERE NEED FOR A MEDICAL INTERVENTION? NO. WAS THERE ANY SAFETY ISSUES AT ALL? NO. WERE ANY OTHER ACTIONS TAKEN DUE TO THE INCIDENT? NO. ARE THERE SAMPLES AVAILABLE TO BE SENT BACK FOR THE INVESTIGATION? IF SO, LET US KNOW AND WE CAN SEND YOU A RETURN LABEL FOR YOUR CONVENIENCE. NO. IF PATIENT IDENTIFIERS ARE KNOWN, PLEASE PROVIDE A FEW SO WE CAN ACCURATELY CAPTURE THIS INFORMATION (GENDER, AGE, DOB, WEIGHT, ETC) NO.

    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, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 362753, BATCH NO: 8243890. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN THE TUBES HAD POOR GEL SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE WOULD LIKE TO REPORT GEL ISSUE ON THE BD CPT LOT NO: 8243890, EXP 2019-09-30. TOTAL OF 3 TUBES WERE COLLECTED FROM THE PATIENT AND SENT WITHIN 24 HOURS. PLEASE COULD YOU PLEASE INVESTIGATE ON THE LOT AND PROVIDE US A DETAILED REPORT. WHAT SPECIFIC DATE DID THIS INCIDENT OCCUR? (B)(6) 2019. CAN YOU PROVIDE THE REF OR PART NUMBER? BD CPT TUBE (SODIUM HEPARIN). WAS THERE ANY SERIOUS INJURY? THIS A CLINICAL TRIAL. WAS THERE ANY EXPOSURE TO BLOOD OR OTHER BODILY FLUID? NO. WERE THERE ANY ERRONEOUS RESULTS? IF SO, NO ANALYSIS. WHAT RESULTS WERE ABNORMAL? WHAT INSTRUMENT WAS USED? WHAT WAS THE CONDITION OF THE SAMPLE? WHAT IS YOUR COLLECTION METHOD? DUE TO THIS INCIDENT, WAS THERE A CHANGE IN COURSE OF TREATMENT? NO. WAS THERE NEED FOR A MEDICAL INTERVENTION? NO. WAS THERE ANY SAFETY ISSUES AT ALL? NO. WERE ANY OTHER ACTIONS TAKEN DUE TO THE INCIDENT? NO. ARE THERE SAMPLES AVAILABLE TO BE SENT BACK FOR THE INVESTIGATION? IF SO, LET US KNOW AND WE CAN SEND YOU A RETURN LABEL FOR YOUR CONVENIENCE, NO. IF PATIENT IDENTIFIERS ARE KNOWN, PLEASE PROVIDE A FEW SO WE CAN ACCURATELY CAPTURE THIS INFORMATION (GENDER, AGE, DOB, WEIGHT, ETC) NO. PICTURE ATTACHED, YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340534 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8243890 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other