BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 7306523 · Received March 1, 2018

    Report

    Report Number
    2210968-2018-71122
    Event Type
    Injury
    Date Received
    March 1, 2018
    Report Date
    February 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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: J GASTROINTEST SURG. 2017; 21:1031¿1037. DOI: 10.1007/S11605-017-3395-0. (B)(4)

    Description of Event or Problem · 1

    LITERATURE ARTICLE: INTRA-OPERATIVE AMYLASE CONCENTRATION IN PERI-PANCREATIC FLUID PREDICTS PANCREATIC FISTULA AFTER DISTAL PANCREATECTOMY POST-OPERATIVE PANCREATIC FISTULA (POPF) CONTINUES TO BE A MAJOR CAUSE OF MORBIDITY AND MORTALITY AFTER DISTAL PANCREATIC RESECTION. IT WAS DEFINED AS A DRAIN FLUID AMYLASE CONCENTRATION ON THE THIRD POST-OPERATIVE DAY GREATER THAN 3 TIMES THE SERUM AMYLASE LEVEL. THE AIM OF THIS STUDY WAS TO ASSESS THE PREDICTIVE VALUE OF INTRA-OPERATIVE AMYLASE CONCENTRATION (IOAC) IN PERI-PANCREATIC FLUID AFTER DISTAL PANCREATECTOMY FOR THE DIAGNOSIS OF POPF. A TOTAL OF 26 PATIENTS UNDERWENT DISTAL PANCREATECTOMY (14 MALE AND 12 FEMALE; AGE RANGE: 47 TO 76 YEARS OLD). DISTAL PANCREATECTOMY WAS PERFORMED THROUGH EITHER A MIDLINE LAPAROTOMY OR A ROOFTOP INCISION. A BLAKE DRAIN FR 15 WAS ROUTINELY PLACED AT THE LEVEL OF THE PANCREATIC REMNANT, BROUGHT OUT THROUGH THE LEFT ABDOMEN, AND PLACED ON FREE DRAINAGE. REPORTED COMPLICATIONS INCLUDED DELAYED GASTRIC EMPTYING IN 1 PATIENT, PULMONARY EMBOLUS IN 1 PATIENT, POST-OPERATIVE HEMORRHAGE IN 1 PATIENT WHICH REQUIRES RETURN TO THE OPERATING THEATER, ACUTE RENAL IMPAIRMENT IN 1 PATIENT, HOSPITAL ACQUIRED PNEUMONIA IN 1 PATIENT, AND POPF IN 10 PATIENTS (3 PATIENTS HAD TYPE B POPF WHICH SUBSEQUENTLY RESOLVED WITHOUT FURTHER INTRA-ABDOMINAL COMPLICATIONS AND 1 PATIENT HAD TYPE C POPF WHICH REQUIRES LAPAROTOMY). IT WAS CONCLUDED THAT THE MEASUREMENT OF IOAC ALLOWS EARLY AND ACCURATE CATEGORIZATION OF PATIENTS AT RISK FOR POPF IN DISTAL PANCREATECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151640 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention