MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/11/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Attempts to obtain the following information have been made and the following has been obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent was the drain broken into two or more pieces? or was it pierced? no further information is available.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.Was the drain replaced? no further information is available.If yes, was a second surgery needed to place the second drain? device return status.We regularly contact with sales rep about the device returning.No further information will be provided.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 an unknown neurosurgery on (b)(6) 2020 and a drain was used.After surgery, when trying to start suction in the ward, air leakage occurred.Then, damage on the drain was found.It is unknown when the damage occurred.The lot number is unknown.Further details are not provided.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/21/2020.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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/2/2020.Additional information: d9.H3 evaluation: received one used drain pc2227.There is a 3mm cut on the drain near the area where it was tied to a patient.Our process includes 100% visual inspection of the drain so it is unlikely that the drain was supplied in this condition.Most probably the drain was damaged in use.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.

Manufacturer Narrative

Product complaint # (b)(4).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 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.

• Brand Name: BLAKE (R) DRAIN 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10447276
• MDR Text Key: 204205506
• Report Number: 2210968-2020-06332
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/12/2020

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
• Device Lot Number: J1920157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 09/01/2020; 10/01/2020; 11/11/2020
• Supplement Dates FDA Received: 09/21/2020; 10/20/2020; 12/03/2020
• Patient Sequence Number: 1