MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 15FR RND W/ 3/16IN TR; CATHETER, IRRIGATION

Catalog Number 2229

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/09/2023

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4) additional information: h6 component code: g07002 - device not returned.Additional information provided: was surgery delayed due to the reported event? --> unknown, was procedure successfully completed? --> unknown, were fragments generated? --> unknown, if yes, were they removed easily without additional intervention? --> unknown, patient status/ outcome / consequences --> no, was other medical intervention (e.G.X-rays, additional procedures, prescriptions, otc, revision) required: --> unknown, is the patient part of a clinical study --> unknown, additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.¿ did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? [ans: ? no, they use it just out of the package] ¿ how was the case completed? [ans: change a new drain with different lot number] 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 Description

It was reported a patient underwent a total mastectomy procedure on an unknown date in 2023 and a drain was used.Dr.Used drain and he found that there is air leak after connecting to the reservoir.Change a new drain with different lot number.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: complaint sample review : one complaint sample of the drain was received for evaluation, no negative observation was identified during visual inspection.Product was also checked functionally, and no non-compliance was noted.Retention sample of complaint lot were checked and found satisfactory.Retention sample review : no negative observation was found.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.It is suspected that, product was mishandled or got misused at user end, and lead to the defect generation.Therefore, further investigation of the received samples is not possible.As per standard practice, 100% functional test and 100% visual inspection was carried out, viz.Before and after packing of finished goods, prior to the product release.There was no scope to miss out 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 15FR RND W/ 3/16IN TR
• Type of Device: 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: 18248260
• MDR Text Key: 329686587
• Report Number: 2210968-2023-09386
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 2229
• Device Lot Number: J2300187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/09/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 12/09/2023
• Supplement Dates FDA Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1