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	Foreign Body In Patient (2687)
Date of Event	01/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent and unknown procedure on an unknown date in 2021 and a drain was used.The drain snapped during removal of drain in the ward.Part of the drain was left in patient's abdomen.Patient underwent additional surgery to have the drain removed.According to the surgeon, there were no issues with the drain but that he may have tightened the fascial stitch too tightly which caused difficulty in drain removal, additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Additional information: did the patient experience a post-op device malfunction? unknown, did the patient experience an adverse event such as infection, non-union, allergic reaction, osteoporosis, overloading, pain, degenerative diseases, bleeding or oozing? unknown, did the patient require revision surgery or hardware removal? yes, was device explanted? false, did patient require revision surgery? false, patient status/ outcome / consequences: yes, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: unknown, is the patient part of a clinical study: unknown, device property of: none, device in possession of: none.Additional information has been requested however not received.If further details are received at a later date a supplemental medwatch will be sent.Date of procedure? procedure name? date of event? where was the drain secured? how was the drain secured? were there any anomalies with the drain: appearance, damage or function prior to use? during or after use? did the drain function as intended? date of drain fragment removal? was a new drain required for use in the patient? is the product lot number available? what is the patient¿s current status? what is the surgeon¿s opinion of the event on the patient consequences? please provide the patient's demographic information including bmi at the time of index procedure product not available for return.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4, h4, h6 component code: g07002 device not returned.Additional information has been requested and obtained.If further details are received at a later date a supplemental medwatch will be sent.1.Date of procedure ¿ (b)(6) 2021.2.Procedure name ¿ gastroscopy video lap subtotal pancreatectomy splenectomy kiv open kiv ramps.3.Date of event - na.4.Where was the drain secured - na.5.How was the drain secured ¿ with silk anchoring.6.Were there any anomalies with the drain: appearance, damage or function prior to use - na.7.During or after use - na.8.Did the drain function as intended - na.9.Date of drain fragment removal - na.10.Was a new drain required for use in the patient - na.11.Is the product lot number available ¿ j2019282.12.What is the patient¿s current status- discharged.13.What is the surgeon¿s opinion of the event on the patient consequences ¿ surgeon does not think that it was an issue with the blake drain but that the fascia stitch was too tight hence hindering the removal process of the drain 14.Please provide the patient's demographic information including bmi at the time of index procedure - na.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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, or its employees that the report constitutes an admission that the product, ethicon, 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.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12829185
• Report Number: 2210968-2021-11598
• Device Sequence Number: 1521131
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• Combination Product (Y/N): N
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2021

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 Expiration Date: 06/23/2025
• Device Model Number: 2230
• Device Catalogue Number: 2230
• Device Lot Number: J2019282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 11/22/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown