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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 device not returned.Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.The fragment remained temporarily in the body.The fragment was retrieved without additional incision.The patient has been in good condition since the procedure.What is the lot number? unk.Was leakage detected? unk.Did the drain break into two or more pieces? yes, two.Please clarify what is meant by "broken part was removed from the patient¿s body" it was retrieved from the body.Did a piece of drain fall into the patient's body? yes.It was broken inside the patient's body.Was the patient taken back to the operating room to remove the broken drain surgically? no.It was retrieved from the body in the same surgeon.Please perform and document the follow up attempt for product return.We regularly contact with sales rep about the device returning.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.

Event Description

It was reported a patient underwent a colorectal surgery on (b)(6) 2023 and a drain was used.In the ward / icu, the drain's connection was ruptured.The broken part was removed from the patient¿s body.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: one complaint sample of flat drain (in two parts) was received for evaluation, during visual inspection it was observed that, both the parts were separated from hub area, and there were visible cut marks on the separation surfaces of both the parts.Documents review : batch manufacturing record review is not performed, as the lot no of complaint is unknown.Retention sample review : retention sample is not checked, as the lot no of complaint is unknown.It is suspected that, hub area of the drain might have come in contact with some sharp tool used prior / during surgery, and lead to the defect generation.External factors like mishandling or improper usage at user end could not be ruled out.Therefore, further investigation of the received samples is not possible.As per standard practice, 100% functional test was performed on the product.Also, 100% visual inspection was carried out, visually before and after packing of finished goods, prior to the product release.So, there was no scope to miss defect, at manufacturing / release stage.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 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18624710
• MDR Text Key: 334496382
• Report Number: 2210968-2024-00872
• 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
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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