BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JVAC UNKNOWN PRODUCT

    MDR report key: 7307182 · Received March 1, 2018

    Report

    Report Number
    2210968-2018-71149
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    February 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    JOL
    PMA / PMN Number
    CL II EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 9/9/2020.

    Additional Manufacturer Narrative · 1

    (B)(4). CITATION: TRANSPLANTATION PROCEEDINGS. 2010; 42: 4555¿4559. DOI: 100.1016/J.TRANSPROCEED.2010.09.159.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: MANAGEMENT OF INTRA-ABDOMINAL DRAIN AFTER LIVING DONOR LIVER TRANSPLANTATION INTRA-ABDOMINAL DRAINS ARE INSERTED DURING THE ORTHOTOPIC LIVER TRANSPLANTATION (OLT) AND MAY PLAY AN IMPORTANT ROLE FOR DRAINAGE IN CASES OF SPLIT-LIVER GRAFTS OR OLT FOR REPEATED PRE-OPERATIVE ABDOMINAL INFECTION. A TOTAL OF 28 PEDIATRIC PATIENTS (15 MALE 13 FEMALE; AGE RANGE: 17 DAYS TO 234 MONTHS) UNDERWENT LEFT LOBE LIVING DONOR LIVER TRANSPLANTATION (LDLT) WITH CHOLEDOCHOJEJUNOSTOMY BILIARY RECONSTRUCTIONS. THE INTRA-ABDOMINAL DRAIN INSERTED DURING LDLT WAS GENERALLY A SINGLE BLAKE SILICON DRAIN (FR 10, FR 15, AND FR19) PLACED UNDER THE RIGHT DIAPHRAGM. DEPENDING ON THE PERI-OPERATIVE FINDINGS, THE GRAFT SIZE, AND OTHER FACTORS, ADDITIONAL DRAINS WERE INSERTED UNDER THE LEFT DIAPHRAGM, IN THE SUBHEPATIC SPACE AND/OR IN DOUGLAS¿ POUCH. CLOSED CONTINUOUS SUCTION WAS USED FOR POST-OPERATIVE MANAGEMENT USING THE J-VAC SYSTEM. THE AUTHORS MEASURED THE AMOUNT OF ASCITIC FLUID PER BODY WEIGHT PER DAY AND SUBDIVIDED THE PATIENTS INTO 4 GROUPS. NINE PATIENTS THAT HAS AN ASCITIC FLUID VOLUME OF 10 ML/KG/D AND AN ASCITIC NEUTROPHIL COUNT OF 250/MM3 ON THE FIFTH POST-OPERATIVE DAY (POD) WERE GROUP A, 9 PATIENTS WITH AN ASCITIC FLUID OF 10 ML/KG/D OR MORE AND ASCITIC NEUTROPHIL COUNT OF LESS THAN 250/MM3 WERE GROUP B, 6 PATIENTS WITH AN ASCITIC FLUID VOLUME LESS THAN 10 ML/KG/D AND ASCITIC NEUTROPHIL COUNT OF 250/MM3 WERE GROUP C, AND 4 PATIENTS WITH AND ASCITIC FLUID VOLUME LESS THAN 10 ML/KG/D AND ASCITIC NEUTROPHIL COUNT FEWER THAN 250/MM3 WERE UNDER GROUP D. THE REPORTED COMPLICATIONS INCLUDED POSITIVE PSEUDOMONAS AERUGINOSA (N-1) AND (B)(6) (N 1) FOR GROUP A AND (B)(6) (N-1), (B)(6) (N-1), AND BILE LEAKAGE OF ANASTOMOTIC SITE (N-1) WHICH WAS TREATED WITH PERCUTANEOUS DRAINAGE FOR GROUP B. FOR GROUP C, THE REPORTED COMPLICATIONS INCLUDED CASE 6, A (B)(6) INFANT WITH POSITIVE ENTEROCOCCUS FAECIUM AT THE DRAIN TIP AND WAS CONSIDERED FOR AN EARLY DRAIN REMOVAL; CASE 13, A (B)(6) INFANT WITH (B)(6) AND BILE LEAKAGE AT THE LIVER TRANSECTION SITE WHICH WAS TREATED WITH PERCUTANEOUS DRAINAGE; CASE 15, A (B)(6) INFANT WITH (B)(6); AND CASE 27, A (B)(6) PATIENT WITH (B)(6) AND RIGHT SUBPHRENIC ABSCESS WHICH WAS TREATED WITH PERCUTANEOUS DRAINAGE. FOR GROUP D, REPORTED COMPLICATIONS INCLUDED CASE 12, AN (B)(6) INFANT WITH POSITIVE PSEUDOMONAS AERUGINOSA. IT WAS REPORTED THAT LONG-TERM PLACEMENT OF A DRAIN MAY LEAD TO RETROGRADE INFECTION AS WELL AS EXCESSIVE OR PROLONGED USE OF ANTIBIOTICS. IF AN ABDOMINAL INFECTION DEVELOPS LATER, IT MUST BE DRAINED AND NEW ANTIBIOTIC TREATMENT INSTITUTED BASED ON CULTURE RESULTS. IT WAS CONCLUDED THAT REMOVAL OF THE DRAIN MAY BE CONSIDERED WHEN THE AMOUNT OF ASCITIC FLUID IS SMALL AND THE ASCITIC NEUTROPHIL COUNT IS GREAT BECAUSE THERE IS THE POSSIBILITY OF RETROGRADE INFECTION OR INTRA-ABDOMINAL INFECTION DUE TO POOR DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149765 JVAC UNKNOWN PRODUCT CATHETER AND TIP SUCTION JOL ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention