MAUDE Adverse Event Report: ETHICON INC. BLAKE 7MM FLAT 3/4; CATHETER, IRRIGATION

Model Number	2216
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The following information was requested, but unavailable: was the retained broken drain piece removed from the patient surgically? no information.Was there additional tissue dissection or damage due to removal of the broken piece? no information.Lot number of the drain.No information.No further information will be provided.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 drain was broken when trying to remove it after a caesarean section procedure in which the drain was placed.The situation was as follows: on (b)(6), the drain was placed inside the patient¿s body for subcutaneous drainage.Five days after the operation, when trying to remove the drain, the surgeon felt that the drain was caught inside the patient¿s body.Then, the tip of the drain was broken off when pulling out the drain from the patient¿s body by excessive force.The broken piece of the drain was retrieved.By x-ray inspection, it was confirmed that no piece of the drain remained in the patient¿s body.The surgeon commented as follows; interrupted suturing was performed under the skin during the operation.There is a possibility that the drain might have been fixed with the suture.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # (b)(4).Received one used drain.Upon visual inspection, the end of the white fluted part of the drain is badly damaged, cut and torn.The drain might be damaged during use and handling.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to fda: 8/31/2020.

• Brand Name: BLAKE 7MM FLAT 3/4
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7320678
• Report Number: 2210968-2018-71326
• Device Sequence Number: 2160184
• Product Code: GBX
• UDI-Device Identifier: 10705031003521
• UDI-Public: 10705031003521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 02/22/2018

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
• Operator of Device: Health Professional
• Device Model Number: 2216
• Device Catalogue Number: 2216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Initial Date Received by Manufacturer: 02/22/2018
• Supplement Date Received by Manufacturer: 04/30/2018; 08/17/2020
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 05/22/2018; 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1