MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 24FR RND; CATHETER, IRRIGATION

Catalog Number	2234
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent abdominal aortic aneurysm -aaa on (b)(6) 2023 and a drain was used.In the ward / icu, the product broke inside the body cavity.The details are the following.The product was used on (b)(6), and the drain was placed.Judgments were made based on ct images until on (b)(6), but there did not appear to be any damage to the product.On (b)(6), there was a possibility of rupture.When the product was removed on (b)(6), it was confirmed that the product was broken.Therefore, the patient was given general anesthesia and the drain was removed.The surgeon suggested some possibilities.There was a possibility that the suture used to secure the drain had been wrapped around the entire circumference of the drain.Also, (normally, the drain is placed closer to the navel than the flank to avoid putting tension on it), but in this case, because the patient had a high bmi, the drain was inserted from the flank, creating like a "hairpin curve" shape as it was left in place, and there was a possibility that it would be under tension and break when it was removed.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information provided: [current status of the patient] the patient was discharged from the hospital.[treatment details] the product was used on (b)(6) during surgery, and the drain was placed.Judgments were made based on ct images until on (b)(6), but there did not appear to be any damage to the product.On (b)(6), there was a possibility of rupture.When the product was removed on (b)(6), it was confirmed that the product was broken.Therefore, the patient was given general anesthesia and the drain was removed.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.How was the drain secured? how was the product function verified following the first activation? who monitored the drainage and how often? please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure were any concomitant procedures performed? is a 2nd procedure performed or scheduled to remove the piece of drain left in the patient? if yes-date of procedure? findings, will piece be returned? 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? surgeon¿s name? if applicable, will product be returned? if so, please provide the return date and tracking information.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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.
Additional Manufacturer Narrative
Product complaint #(b)(4).How was the drain secured? the surgeon suggested some possibilities.There was a possibility that the suture used to secure the drain had been wrapped around the entire circumference of the drain.Also, (normally, the drain is placed closer to the navel than the flank to avoid putting tension on it), but in this case, because the patient had a high bmi, the drain was inserted from the flank, creating like a ""hairpin curve"" shape as it was left in place, and there was a possibility that it would be under tension and break when it was removed.How was the product function verified following the first activation? no problem who monitored the drainage and how often? unk.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure? high bmi.Were any concomitant procedures performed? no.Is a 2nd procedure performed or scheduled to remove the piece of drain left in the patient? yes, the piece was removed under anesthesia.If yes-date of procedure? (b)(6).Findings, will piece be returned? yes.Other relevant patient history/concomitant medications? no.What is the physician¿s opinion as to the etiology of or contributing factors to this event? the surgeon suggested some possibilities.There was a possibility that the suture used to secure the drain had been wrapped around the entire circumference of the drain.Also, (normally, the drain is placed closer to the navel than the flank to avoid putting tension on it), but in this case, because the patient had a high bmi, the drain was inserted from the flank, creating like a ""hairpin curve"" shape as it was left in place, and there was a possibility that it would be under tension and break when it was removed.What is the patient's current status? discharged.Surgeon¿s name? (b)(6).If applicable, will product be returned? the device has been shipped.H3 evaluation: one complaint sample of drain of around 300 mm, was received for evaluation.During visual inspection, it was found that drain was separated from the hub area, and there were visible cut marks present on the surface of separation area of the drain.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.Retention sample of complaint lot were checked and found satisfactory.It is suspected that, hub area of the drain might have came in contact with some sharp tool used prior or during surgery, and lead to the defect generation.External factors like mishandling or improper usage at user end could not be ruled out.Therefore, further investigation of the received samples is not possible.As per standard practice, 100% functional test and 100% visual inspection was carried out visually, before and after packing of finished goods, prior to the product release, 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 HBLS 24FR RND
• 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 ; 9083863534
• MDR Report Key: 18236060
• Report Number: 2210968-2023-09285
• Device Sequence Number: 7152429
• Product Code: GBX
• UDI-Device Identifier: 10705031003620
• UDI-Public: 10705031003620
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2234
• Device Lot Number: J2224873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/07/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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