MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 19FR RND; CATHETER, IRRIGATION

Catalog Number	2230
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
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 however not received.If further details are received at a later date a supplemental medwatch will be sent.It was mentioned to be in the intramedullary cavity and intrathecal.Please specify where is the drain piece retained in the body? date of initial procedure? were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? how was the product function verified following the first activation? 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? what symptoms did the patient experience following the index surgical procedure? onset date? is a 2nd procedure performed or scheduled to remove the piece of drain left in the patient? if yes-date of procedure? if removal performed, what are the 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? product lot number? no product is 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 surgery on an unknown date and a drain was used.Part of the product that was removed has been discarded.The broken tip still remains inside the body (intrathecal).The drain was removed around (b)(6) 2023 of this year, and because it was removed without any discomfort at the time of removal, the surgeon was unaware that it remained inside the body.When an x-ray was performed on (b)(6) 2023, the surgeon found that part of the drain remaining in the intrathecal.Further details are not provided.No sample will be returned.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Additional information: h6 component code: g07002 - device not returned.Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Date of initial procedure? on (b)(6) 2023.Were there any intra-operative complications? if so, what were they? no, at removal.Where was the tip of drainage tube located? medullary cavity.How was the drain secured? normally.How was the product function verified following the first activation? unk.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure? unk.The diagnosis and indication for the index surgical procedure? surgery for implant removal due to infection.Were any concomitant procedures performed? no.What symptoms did the patient experience following the index surgical procedure? onset date? no.Is a 2nd procedure performed or scheduled to remove the piece of drain left in the patient? it is under considering in the hospital.If yes-date of procedure? n/a.If removal performed, what are the findings, will piece be returned? not removed.Other relevant patient history/concomitant medications? not reported.What is the physician¿s opinion as to the etiology of or contributing factors to this event? it is difficult to notice that the product has broken.What is the patient's current status? the piece was left, but no problem.Surgeon¿s name? unk.Product lot number? unk.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 19FR 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 ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17638542
• Report Number: 2210968-2023-06240
• Device Sequence Number: 14945010
• Product Code: GBX
• UDI-Device Identifier: 10705031003583
• UDI-Public: 10705031003583
• 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): 09/01/2023

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 2230
• 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: Not provided
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 09/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown