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

Model Number 2227

Device Problem Leak/Splash (1354)

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

Event Date 05/14/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested and received.Attempts have been made to obtain the device.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? 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 broken into two or more pices? no.There had been a hole on the drain.Was the drain with the hole removed completely from the patient? a part of the drain containing the hole was cut, and removed.The rest of the drain was reconnected to the reservoir, and it was used continuously.Was the patient taken back to the operating room to reconnect the drain surgically? no further information is available.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.

Event Description

It was reported a patient underwent a cesarean section on (b)(6) 2021 and a drain was used.After surgery, when the patient was checked at the ward, it was found that there had been a hole at about 20 cm point outside the body.Therefore, the drain including the hole was cut to a certain length and reconnected to the reservoir.Further details are not provided.There were no adverse consequences to the patient.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 7/27/2021.Additional information: d9.H3 evaluation: sample was received for evaluation.After opening the pack one used drain sample was found.There were black particles inside the drain.The drain sample was not complete in length, the drain length was 300mm however, the length of complete drain is 1200mm.The location of drain broken (hole) could not be verified.There was no evidence to verify.The location of drain broken (hole) could not be 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, 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 (R) DRAIN 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11952495
• MDR Text Key: 268283658
• Report Number: 2210968-2021-05330
• 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: 05/14/2021

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
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Manufacturer Received: 05/14/2021
• Initial Date FDA Received: 06/07/2021
• Supplement Dates Manufacturer Received: 06/29/2021
• Supplement Dates FDA Received: 07/27/2021
• Patient Sequence Number: 1