MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 24FR RND; CATHETER, IRRIGATION

Model Number	2234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hernia (2240)
Date of Event	07/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a laparoscopic pyeloplasty on (b)(6) 2022 and a drain was used.Patient taken to surgery, at the time of removal of the device a epiplocele developed.A revision surgery done on (b)(6) 2022 to reduce epiplocele under local anesthesia additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).Additional information provided: did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? --> yes, did the patient require revision surgery or hardware removal? yes, was device explanted? true, did patient require revision surgery? false, reason for revision surgery.Epiplocele, if no, was there any additional medical intervention required such as x-rays, additional procedures, prescriptions? reduce epiplocele under local anesthesia, patient status/ outcome / consequences: yes, patient consequence description/was there a clinical outcome experienced by the patient (infection, inflammation, etc.)? epiplocele, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, if yes, describe removal of the device an epiplocele is produced, is the patient part of a clinical study: unknown, event description: patient taken to laparoscopic pyeloplasty (june 15) in whom a 19-fr drain was used and at the time of device removal, presented an epliplocele as an adverse event.Reduction is achieved under local anesthesia in the hospitalization service.With the use of the penrose drain, we had not had any complications of these characteristics in the past and we consider that there is no error in the device removal technique, but rather that due to its design it favors the risk of presenting complications such as the one described.This device (dren) has external grooves that probably cause the omentum to adhere and explains the events described.If further details are received at a later date a supplemental medwatch will be sent.No product available for return.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 HBLS 24FR RND
• 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 ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15514227
• Report Number: 2210968-2022-08080
• Device Sequence Number: 20313441
• Product Code: GBX
• UDI-Device Identifier: 10705031003620
• UDI-Public: 10705031003620
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2022

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 Expiration Date: 12/08/2025
• Device Model Number: 2234
• Device Catalogue Number: 2234
• Device Lot Number: J2032006
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2022
• Initial Report FDA Received Date: 09/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2020
• 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 Age: 4 YR
• Patient Sex: Male