MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 10MM FLAT FULL FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Model Number	2215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Scar Tissue (2060); Foreign Body In Patient (2687)
Date of Event	03/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Component code: g07002 - device not returned.Additional information has been requested and received.If further details are received at a later date a supplemental procedure name? bodylift.It was noted that this occurred ¿intra operatively¿ is that accurate? a second procedure was needed to remove without replacing the drain.If yes, was the drain replaced during that same /initial procedure? a second procedure was needed to remove without replacing the drain.Or was a 2nd procedure required remove and to place a new drain? a second procedure was needed to remove without replacing the drain.Were there any intra-operative complications? no.Where was the tip of drainage tube located? under the scar.How was the drain secured? attached to the skin with 2-0 vicryl.What was the date of first activation? at the end of the first intervention.How was the product function verified following the first activation? checking the hold of the fastener by pulling on it, holding the vacuum.Who monitored the drainage and how often? ward nurse, 3 times a day.When was the breakage first noted? loss of the vacuum at the post-op d+2.Observation of rupture of the redon on the post-op d+4 even before the attempt to remove it.The diagnosis and indication for the index surgical procedure? sequels of weight loss.Were any concomitant procedures performed? no.What symptoms did the patient experience following the index surgical procedure? onset date? loss of the vacuum at the post-op d+2.What is the physician¿s opinion as to the etiology of or contributing factors to this event? defect of solidity of the transparent and white junction of the redon.What is the patient's current status? small scarring problem at the level of the surgical revision.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 a bodylift procedure on and unknown date and a drain was used.Device defective, loss of the vacuum at the post-op day 2.Observation of rupture on the post-op day 4, even before the attempt to remove it.A second procedure was needed to remove without replacing the drain.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 W/ 3/16IN TR
• 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 ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 16663591
• Report Number: 2210968-2023-02281
• Device Sequence Number: 20487216
• Product Code: GBX
• UDI-Device Identifier: 10705031003514
• UDI-Public: 10705031003514
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 04/04/2023

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 Model Number: 2215
• Device Catalogue Number: 2215
• 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: 03/13/2023
• Supplement Date Received by Manufacturer: 04/04/2023
• Initial Report FDA Received Date: 04/03/2023
• Supplement Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 2-0 VICRYL
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown