MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 7MM FLAT FULL FLUTED; CATHETER, IRRIGATION

Catalog Number	2211
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional 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? no, 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 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.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? was the drain broken into two or more pieces? if no, please clarify what was the quality issue experienced with the product? were any pieces left inside the patient? if yes, was the patient taken back to the operating room to remove the broken drain surgically? 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.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2024 and drain was used.During the procedure, the 7 fr drain is performed through the skin hole, which is where it breaks in the white part.Normally, this does not happen in this maneuver.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional information: d4 udi.H3 evaluation: no product sample has been received.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.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.There was no scope to miss such claimed 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 7MM FLAT FULL FLUTED
• 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: 19627368
• Report Number: 2210968-2024-06690
• Device Sequence Number: 7065349
• Product Code: GBX
• UDI-Device Identifier: 10705031003477
• UDI-Public: (01)10705031003477(11)221209(17)271219(10)J2229094
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2211
• Device Lot Number: J2229094
• 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: 06/01/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2022
• 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
• Patient Sex: Unknown