MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 10MM FLAT FULL FLUTED; CATHETER, IRRIGATION

Catalog Number	2214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested and received.- did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? i do not know but it was a surgeon who has used them without incidence for years and he had 2 drains separated is a few weeks.Dr padilla - it was reported that the drain separated and dislodged in the patient twice.Could you please confirm whether the same drain separated and dislodged on two separate occasions, or if two different drains had this reported issue? yes two separate drains in two separate procedures.In one patient the patient had to go to the cath lab to have the dislodged end of the catheter removed.- could you please confirm if a broken drain is being reported in this case? drain were broken - please provide the lot number: j2225066.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.I was unable to get any additional information.Procedure name? date of procedure? date of event where product had an issue? were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? what was the date of first activation? how was the product function verified following the first activation? who monitored the drainage and how often? was leakage detected? if so, where? was another product used? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? were any concomitant procedures performed? date 2nd procedure performed to remove the piece of drain? other relevant patient history/concomitant medications? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? will product be returned? if so, please provide the return date and tracking information.No product available for return.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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date in 2023 and a drain was used.The drain separated and dislodged in the patient.Patient had to go to the cath lab to have the dislodged end of the catheter removed.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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.
Additional Manufacturer Narrative
Product complaint # (b)(4).H3 evaluation: 'no sample will be returned'.Documents review : during investigation of complaint, batch review of in-process and final packaging inspections, as well as the manufacturing process is performed, these products are reported to be manufactured, inspected, and packaged in conformance with customer's specifications and have been found to be acceptable within all parameters.No discrepancy as per the reported defect is observed.Retention sample review : no negative observation was found.A per standard practice, 100% visual inspection was carried out, visually before and after packing of finished goods, prior to the product release.Also, 100% functional test was performed.There was no scope to miss such defect, at manufacturing / release stage.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 SI DRAIN 10MM FLAT FULL FLUTED
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.; 1000 route 202; raritan 08869 0151
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18236058
• Report Number: 2210968-2023-09282
• Device Sequence Number: 7152428
• Product Code: GBX
• UDI-Device Identifier: 10705031003507
• UDI-Public: 10705031003507
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2024

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 Catalogue Number: 2214
• Device Lot Number: J2225066
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 12/04/2023; 01/19/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/13/2023; 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown