MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Model Number 2231

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/18/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.

Event Description

It was reported that the patient underwent an unknown procedure and drain was used.The drain was removed postoperatively by an caregiver on (b)(6) 2017.Ct images were made on (b)(6) 2017.The ct images showed that a part of the drain was left in the abdomen of the patient.Re-operation for the removal of the drain was necessary, this was carried out on (b)(6) 2017.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 9/8/2020.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7425381
• MDR Text Key: 105290254
• Report Number: 2210968-2018-72102
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003590
• UDI-Public: 10705031003590
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2231
• Device Catalogue Number: 2231
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention