BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DC BEAD

    MDR report key: 7372620 · Received March 27, 2018

    Report

    Report Number
    3002124543-2018-00020
    Event Type
    Injury
    Date Received
    March 27, 2018
    Date of Event
    February 13, 2018
    Report Date
    March 2, 2018
    Manufacturer
    BIOCOMPATIBLES UK LTD
    Product Code
    KRD
    UDI-DI
    05060116920109
    PMA / PMN Number
    K094018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED: 11-APR-2018. FIELDS UPDATED: EXPIRATION DATE 08/31/2020. BATCH REVIEW AS FOLLOWS: A BATCH RECORD REVIEW (BATCH NUMBER: 7000396-4 (INTERMEDIATE BATCH NUMBER: 7000396) WAS PERFORMED AS FOLLOWS: THE FOLLOWING DOCUMENTATION WAS REVIEWED IN RESPONSE TO THIS COMPLAINT: I) FAR-BR-02.038 MANUFACTURE OF 7-11: DYEING, EXTRACTION AND SIEVING; II) FAR-BR-02.019 SEMI-AUTOMATED FILLING AND PRIMARY PACKAGING OF 7-11 VIALS; III) FAR-13-TM2177-F01 EMBOLIC SIZING WORKSHEET FOR BATCH RELEASE; IV) FAR-SP-13.026-F01 QC VISUAL INSPECTION OF EMBOLICS PRODUCT; V) FAR-BR-02.011 LC/DC BEAD LABELING AND PACKAGING (7000396-4); VI) FAR-SP-13.019-T06 QC CERTIFICATE OF ANALYSIS. FROM A REVIEW OF THE DOCUMENTATION LISTED ABOVE, IT WAS CONCLUDED THAT THE MANUFACTURING, TESTING AND RELEASE PROCESSES FOR DC BEAD BATCH 70000396-4 WERE COMPLETED SATISFACTORILY IN COMPLIANCE TO APPLICABLE PROCEDURES AND THAT THIS BATCH HAD PASSED ALL ITS QUALITY CONTROL TESTING PARAMETERS. NO QUALITY EVENTS WERE IDENTIFIED THAT WERE DEEMED TO HAVE ANY SIGNIFICANT IMPACT ON PRODUCT QUALITY, EFFICACY AND PATIENT SAFETY. CONCLUSION: NO POTENTIAL DEFICIENCIES WERE IDENTIFIED IN THE MANUFACTURING, TESTING AND RELEASE PROCESSES FOR DC BEAD BATCH 70000396-4 AND NO ATTRIBUTABLE EVENT WAS FOUND IN ANY ASSOCIATED QES THAT COULD HAVE LED TO THIS COMPLAINT. AS A RESULT OF THE MANUFACTURER'S INVESTIGATION AND ITS CONCLUSIONS; NO REMEDIAL ACTION/CORRECTIVE ACTION/PREVENTIVE ACTION / FIELD SAFETY CORRECTIVE ACTION ARE REQUIRED. THIS REPORT IS CONSIDERED FINAL.

    Additional Manufacturer Narrative · 1

    DC BEAD LOADED WITH EPIRUBICIN 150MG WAS REPORTED TO HAVE BEEN USED IN THE TREATMENT OF THIS PATIENT. THE EQUIVALENT PRODUCT LC BEAD IS AVAILABLE IN THE USA AND IS INDICATED FOR THE TREATMENT OF HYPERVASCULAR TUMORS AND AVMS. DC BEAD LOADED WITH EPIRUBICIN IS CONSIDERED OFF-LABEL USE. THE PHYSICIAN REPORTED THAT THE PATIENT DEVELOPED PANCREATITIS AFTER RECEIVING EMBOLIZATION WITH DC BEAD WITH EPIRUBICIN, BUT NO OTHER DETAILS AS TO SEVERITY OF PANCREATITIS OR TREATMENT HAVE BEEN PROVIDED TO DATE. THE PATIENTS UNDERLYING DISEASE AND CONTRIBUTING FACTORS ARE UNKNOWN. DUE TO THE LACK OF INFORMATION IT IS NOT POSSIBLE TO ASSESS THE SERIOUSNESS OF THE REPORTED EVENT OF PANCREATITIS AND THEREFORE WERE ARE REPORTING THIS CASE WITH AN ABUNDANCE OF CAUTION. NO MALFUNCTION WAS REPORTED. THE INCIDENT IS CURRENTLY UNDER INVESTIGATION (INCLUDING A REVIEW OF BATCH HISTORY RECORDS) AND THE CONCLUSION OF THIS INVESTIGATION WILL BE COMMUNICATED AS A FINAL REPORT. ANY NEW SIGNIFICANT INFORMATION RECEIVED BY THE MANUFACTURER BETWEEN NOW AND THE CONCLUSION OF THE MANUFACTURER'S INVESTIGATION, WILL BE COMMUNICATED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    EMBOLISATION OF 1 PATIENT ON (B)(6) 2018 WITH DC BEAD LOADED WITH EPIRUBICIN 150MG, THE PATIENT GETS ACUTE PANCREATITIS AT NIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218163 DC BEAD HCG/KRD SINGLE USE IMPLANTABLE MEDICAL DEVICE KRD BIOCOMPATIBLES UK LTD 100 - 300¿M 7000396-4 05060116920109

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other DC BEAD LOADED WITH EPIRUBICIN (150MG).| DC BEAD LOADED WITH EPIRUBICIN (150MG)