MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Catalog Number 2217

Device Problem Leak/Splash (1354)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a urological surgery on (b)(6) 2023 and a drain was used.During procedure, the product was used for tpl (kidney transplant donor).The product was implanted in the retroperitoneal cavity.On (b)(6) 2023, in the ward / icu, tear of the drain was observed at the beginning of the groove.The surgeon resected the narthex and the torn portion, and attempted tape fixation.However, it was later determined that the drain needed to be replaced, and the drain was replaced with another one under ct guidance.[current status of the patient] the patient was discharged from the hospital.[progress] the drain was replaced and the progress is fine.[health injury details] effluent failure.The following action was taken before impact.[treatment details] the drain was replaced under ct guidance.Further details are not provided.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: [treatment plan] none.[seriousness] non-serious (moderate/minimal).[reason of the seriousness] since the replacement, the progress is good.[surgeon¿s opinion about causal relationship between product and event] no.[surgeon¿s comment] ¿i have been using product for years now and this event has never happened before.¿ additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Why are 2 drains being returned? did 2 drains have an issue during surgery for the patient? were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? how was the product function verified following the first activation? who monitored the drainage and how often? when was the malfunction first noted? was leakage detected? if so, where? was another product used? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? what symptoms did the patient experience following the index surgical procedure? onset date? what was date of 2nd procedure performed to replace the drain via guided ct? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6.Health effect - clinical code.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Why are 2 drains being returned?: 1 drain is the complaint product and another one is a reference product.(only representative sample drain received.).Did 2 drains have an issue during surgery for the patient? no, just one.Were there any intra-operative complications? if so, what were they? no.Where was the tip of drainage tube located? placed in the retroperitoneal cavity.How was the drain secured? unk.How was the product function verified following the first activation? unk.Who monitored the drainage and how often? unk.When was the malfunction first noted? 21th july 2023.Was leakage detected? if so, where? no.Was another product used? yes.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: unk.Date and name of index surgical procedure? (b)(6) 2023.The diagnosis and indication for the index surgical procedure? tpl: transplantation.The malfunction with this product occurred in the donor.Were any concomitant procedures performed? replaced drain.What symptoms did the patient experience following the index surgical procedure? onset date? unk.What was date of 2nd procedure performed to replace the drain via guided ct? (b)(6) 2023.Other relevant patient history/concomitant medications? unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event? unk.What is the patient's current status? unk.H3 evaluation: complaint sample review : one sealed pouch was received as complaint sample for evaluation, product was well in place and intact in original packing.Product was check visually, without opening the received sample.No negative observation was identified during visual inspection.Retention sample of complaint lot were checked and found satisfactory.Documents review : during investigation of complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process is performed, these products are reported to be manufactured, inspected, and packaged in conformance with customer's specifications and have been found to be acceptable within all parameters.No discrepancy as per the reported defect is observed.Retention sample review : no negative observation was found.Actual sample not returned for analysis.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BLAKE SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17616207
• MDR Text Key: 321881374
• Report Number: 2210968-2023-06177
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2217
• Device Lot Number: J2210281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/24/2023
• Supplement Dates Manufacturer Received: 09/11/2023; 10/05/2023
• Supplement Dates FDA Received: 10/04/2023; 10/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention