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 Codes	Foreign Body In Patient (2687); Not Applicable (3189)
Date of Event	07/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Attempts to obtain the following information have been made but has not been obtained.What is the current status of the patient? patient was doing ok, in spite of the additional surgery.Attempts to obtain the following information have been made but has not been obtained.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Were any anomalies noted of the drain condition upon placement? did the drain come in contact with sharp objects at any time: surgical instruments, surgical needles, sutures,? did the drain function as intended? was drain removed after fulfilling need? where was the tip of drainage tube located? how was drain secured? please provide patient demographic information: age, gender, weight, bmi at the time of the index procedure? lot number of drain? what is the physician¿s opinion as to the etiology of or contributing factors of this event? response: i¿m afraid it¿s not possible to get any of this further info.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported a patient underwent a cabg on an unknown date and a drain was used.Post operatively, nurse attempted remove pericardial drain as per protocol and resistance felt.Doctor reviewed patient and informed staff that difficult drain removal was expected due to difficult insertion (small incision).Drain tubing snapped on attempted removal, leaving remaining part of drain tube internally.The patient had to return to surgery to have the broken part of the drain removed.The external drain segment was retained for collection.The internal drain segment was not retained.It is unclear whether the drain was accidently sutured in, as the internal part of drain was not retained post-removal.Patient had an additional surgical procedure to have broken drain segment removed ¿ resulting in possible increased length of stay, and prolonged recovery time from cumulative surgical procedures.Patient was doing ok.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: (b)(6) 2020.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/13/2020.H3 evaluation: product received for analysis.Received one 30 cm long piece of 19fr blake round fluted drain, with its proximal end attached to the adapter.The distal end is broken near the black dot area.The broken surface has uneven and indented character; such appearance is typical for breakage following some mechanical pre-damage like small cut or nick.Since the drain broke near the black dot, we can assume that the drain may be sewed in this area.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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 19FR R/F
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10446175
• Report Number: 2210968-2020-06330
• Device Sequence Number: 19531741
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2230
• Device Catalogue Number: 2230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 08/17/2020; 09/30/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/24/2020; 10/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention