MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 10FR RND W/ 1/8IN; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

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

Event Date 04/14/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).H6 component code: g07002 ¿ device not returned.Additional information provided: it was not a complete lack of suction, but swelling was faster than usual.The surgeon continued to use the product until the drain was removed.There is no problem with the patient's condition.Additional information has been requested and received.Attempts to obtain the product sample have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number of the blake drain? unk.What is the lot number of the jvac reservoir? unk.What is the lot number of the blake drain? unk.Was it determined where the air leak occurred (drain or reservoir)? no.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.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 by a sales rep that, during an unknown otorhinolaryngologic surgical procedure, the product was placed subcutaneously.In the ward / icu, it was unknown how many times suction was applied until then, but when a nurse tried to flap up, the reservoir immediately swelled and suction could not be done anymore.*product code of the drain was not in the ecm, so i registered as "unknown_ethinc" but the product code of the drain was 2227.Further details are not provided from the hp.When we send the samples to you, we will let you know its return date and tracking number.There were no adverse consequences to the patient.Affiliate reference number is (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: product sample received for analysis.One complaint sample of drain with connector is received for evaluation, no negative observation during visual inspection.Product is checked functionally, and found in compliance.As per standard practice, 100% suction 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 out such defect, at manufacturing / release stage.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 these factors are out of scope.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 10FR RND W/ 1/8IN
• 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: 17037168
• MDR Text Key: 316328997
• Report Number: 2210968-2023-03974
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• 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: 07/18/2023

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: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 06/01/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 06/30/2023
• Supplement Dates FDA Received: 06/01/2023; 07/18/2023
• 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