MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND W/ 1/4IN BNDBLE TR; CATHETER, IRRIGATION

Model Number 2232

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: component code: g07002 - device not returned.Additional information has been requested and received.What is the lot number? unk.Please clarify, was the drain broken into two or more pieces? no, the drain was not broken.There was just a scratch under the insertion site.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.We regularly contact with sales rep about the device returning.The surgery was a thoracoscopic surgery, and the product was placed in a port wound in the chest.The drain came off on the same day as surgery.When the drain came off, it was immediately replaced with another drain.No infection has occurred, and the patient has already been discharged from the hospital.Additional information has been requested however not received.Attempts have been made to obtain the device.If further details are received at a later date a supplemental medwatch will be sent.It was noted the drain was removed and a new drain was replaced.Was the new drain placed during a 2nd surgery performed with surgical intervention ? or was it done without surgical intervention, via a port wound in the chest? what was the reported issue with the bcc1 / cardio connector? why was it returned? 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 respiratory surgery on (b)(6) 2023 and a drain was used.In the ward/icu, the drain placed on the patient came off.The details are following.Contamination and liquid leakage around the insertion site of the product were noted, and when it was checked, there was a tear like scratch under the insertion site.When the surgeon tried to reinforce it with tegaderm, the drain came out.It is unknown whether the scratch on the product was originally there or was caused by using the product.·the drain came off on the same day as surgery.· when the drain came off, it was immediately replaced with another drain.·no infection has occurred, and the patient has already been discharged from the hospital.Further details are not provided.There were no adverse consequences to the patient.Additional information has been requested.

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.It was noted the drain was removed and a new drain was replaced.Was the new drain placed during a 2nd surgery performed with surgical intervention ? or was it done without surgical intervention, via a port wound in the chest? 2nd drain was inserted via port wound.What was the reported issue with the bcc1 / cardio connector? not reported.Why was it returned? the surgeon requested us the investigation.H3 evaluation: no discrepancy as per the reported defect was observed.One complaint sample of drain of around 300 mm with connector was received for evaluation, during visual inspection, no negative observation was identified, except short length of the drain.Furthermore, functional test (manual suction) was performed with received drain, and it was found ok functionally.Retention sample is not checked, as the lot no.Of the complaint is unknown.As per standard practice, 100% inspection was carried out, viz.Before and after packing of finished goods, prior to the product release.So, there was no scope at end to missed out such defect, at manufacturing / release stage.Batch manufacturing record review is not performed, as the lot no.Of the complaint is unknown.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 19FR RND W/ 1/4IN BNDBLE 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: 16622351
• MDR Text Key: 312362023
• Report Number: 2210968-2023-02106
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2232
• Device Catalogue Number: 2232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 04/26/2023
• Supplement Dates FDA Received: 05/23/2023
• 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