MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Catalog Number	2230
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a total laparoscopic hysterectomy on an unknown date in (b)(6) 2024 and a drain was used.When removed the drain, the greater omentum had pulled out from the wound and had not fitted, so it had to do emergency surgery.Further details are not provided.No sample will be returned.Patient status is stable.The patient was discharged from the hospital.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information provided: the procedure was tlh: total laparoscopic hysterectomy.The drain was 15fr.In the emergency procedure, the negative pressure was released, and the sutures were removed, and the drain was removed.The greater omentum had pulled out, so the omentum was cut.The procedure was performed in (b)(6), and the patient status is stable.The patient was discharged from the hospital.The doctor commented that the drain was used properly, and the black point of the drain was not around outer skin.It was possible that the drain moved after the procedure, and the drain pulled out the greater omentum.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.What is the alleged deficiency of the drain? date of procedure? date of event where product had an issue? were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? what was the date of first activation? how was the product function verified following the first activation? who monitored the drainage and how often? was any issues detected? if so, where? did the drain fulfill its use/need? was another product used? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? other relevant patient history/concomitant medications? surgeon¿s name? product lot number? no product is available for return.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.What is the alleged deficiency of the drain? the drain entangled the omentum.Date of procedure? (b)(6) 2024.Date of event where product had an issue? 2 days post-op.Were there any intra-operative complications? if so, what were they? no intra-op complication.Where was the tip of drainage tube located? unk.How was the drain secured? normally.What was the date of first activation? in initial surgery.How was the product function verified following the first activation? unk.Who monitored the drainage and how often? unk.Was any issues detected? if so, where? the drain entangled the omentum but the surgeon said the drain was secured properly.Did the drain fulfill its use/need? yes.Was another product used? no, reoperation.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure: female.The diagnosis and indication for the index surgical procedure? unk.Were any concomitant procedures performed? no.Other relevant patient history/concomitant medications? no.Surgeon¿s name? (b)(6).Product lot number? unk.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 (R) DRAIN 19FR R/F
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19512253
• Report Number: 2210968-2024-06075
• Device Sequence Number: 15332305
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown