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

Model Number	2230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.How was the case completed? was any additional tissue dissection performed to remove the broken drain? if yes, what surgical/medical intervention was performed? was a new drain inserted in the patient surgically? was the drain removed in icu or in surgical room? was a new drain placed in icu or in surgical room? the device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and drain was attached to a reservoir.It was reported that the patient changed position and the drain was broken.The patient's drain was removed.Additional information is has been requested.
Additional Manufacturer Narrative
Pc-(b)(4).Additional information was requested and the following was obtained: how was the case completed? in the uci the patient was changed position and when draining the reservoir, the drain was broken.Was any additional tissue dissection performed to remove the broken drain? no.Was a new drain inserted in the patient surgically? no, because only was reservoir.Was the drain removed in icu or in surgical room? uci.Was a new drain placed in icu or in surgical room? the reservoir in uci.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/21/2020.

• 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: 7168887
• Report Number: 2210968-2018-70072
• Device Sequence Number: 16864070
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (Y/N): N
• PMA/510(K) Number: K953655
• 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): 12/21/2017

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 Expiration Date: 05/31/2022
• Device Model Number: 2230
• Device Catalogue Number: 2230
• Device Lot Number: J1705229
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2017
• Supplement Date Received by Manufacturer: 01/31/2018; 08/17/2020
• Initial Report FDA Received Date: 01/05/2018
• Supplement Report FDA Received Date: 02/02/2018; 08/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR