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

Model Number 2227

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 07/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional information: the lot number is unknown, however two possible lot numbers: j1916942 and j1919959.Attempts have been made to obtain the device.The device has not been received.If further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported a patient underwent an open surgery for intraarticular fracture of right joint of the knee on (b)(6) 2020 and drain was used.In the ward, (b)(6) 2020, a part of the drain was broken after removal of the drain, and the broken drain piece remained in the body.It was removed by reopening the surgical site.The lot number is unknown.There was no problem during the drainage.The broken parts were two.One was the tip in the patient and another was the near area of the reservoir.Dr.Commented that the cause of the broken drain, tip was touching the needle.The patient is stable.No additional treatment is planned.Additional information provided: the drain had been already cut near the reservoir before removing the reservoir.This might have been due to the patient.(based on the observation of the drain,) when the surgeon pulled the rest of the drain, it was broken at the position between inside and outside of the patient¿s body.Milking was performed digitally.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/9/2020.Corrected data: g5.Additional information: d4 , h4 the actual device lot number associated with this event is not known.The reporter provided the following possible lot numbers: lot # j1916942, date of manufacture: 07/1/2019, expiration date: 7/31/2024.Lot # j1919959, date of manufacture: 8/1/2019, expiration date: 8/31/2024.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.H3 evaluation: received one used 10fr drain.The distal part of the drain is broken off at ~15 cm.The drain apparently broke in the transition section since its surface is uneven and indented.Manufacturer production process includes tensile strength testing and 100% visual inspection of drains for damages.The tensile strength results for both lots were in specification and there were no in-process rejects for mechanical damages in these drains.The drain most likely tore following some damage during its use.The complaint is not verified.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: 10370111
• MDR Text Key: 201833341
• Report Number: 2210968-2020-05886
• 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
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• 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
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 08/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR