MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Bacterial Infection (1735); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent to the fda: 3/1/2018.(b)(4).Citation: transplantation proceedings.2010; 42: 4555¿4559.Doi: 10.1016/j.Transproceed.2010.09.159.

Event Description

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) for group a and staphylococcus epidermidis (n-1), (b)(6), 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) old infant with positive enterococcus faecium at the drain tip and was considered for an early drain removal; case 13, a (b)(6) old infant with positive staphylococcus epidermidis and bile leakage at the liver transection site which was treated with percutaneous drainage; case 15, a (b)(6)old infant with positive staphylococcus epidermidis; and case 27, a (b)(6) old patient with positive (b)(6) and right subphrenic abscess which was treated with percutaneous drainage.For group d, reported complications included case 12, (b)(6) old 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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/9/2020.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7307160
• MDR Text Key: 101299168
• Report Number: 2210968-2018-71147
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention