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

Model Number	2231
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	02/18/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/8/2020.

• Brand Name: BLAKE (R) DRAIN 19FR R/F
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7425381
• Report Number: 2210968-2018-72102
• Device Sequence Number: 1271102
• Product Code: GBX
• UDI-Device Identifier: 10705031003590
• UDI-Public: 10705031003590
• Combination Product (Y/N): N
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2231
• Device Catalogue Number: 2231
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/29/2018
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 04/12/2018
• Supplement Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention