MAUDE Adverse Event Report: ETHICON INC. BLAKE 10FR RND DRN 1/8IN BNDBLE BLUNT TR; CATHETER, IRRIGATION

Catalog Number 2241B

Device Problem Break (1069)

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

Event Date 09/29/2022

Event Type  malfunction  

Event Description

It was reported a patient underwent a spinal surgery on (b)(6) 2022 and a drain was used.During surgery, through normal way of using, the trocar was inserted and it was tried to be taken out from the epidermis, but the connection part between the product and the tube was broken immediately.The product was used on subcutaneous.Further details are not provided.There were no adverse consequences to the patient.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? j1920858.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.How was the case completed? no further information is available.What is the current condition of the patient? no further information is available.Device return status: the device has been received at sukagawa and will be shipped.Please check rmao.Qty to be returned : 1 = 2.Qty of product involved : 1 = 2.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Note: events reported on mw# 2210968-2022-08479.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.

Manufacturer Narrative

Product complaint # (b)(4).Additional information: d9 h3 evaluation: two complaint samples were received for evaluation.During visual inspection, partial part of drain is found adhered to embedded area of the trocar, which shows that bonding between needle and drain is strong visible impression marks are also found on the needle side of the trocar, which indicate that some external factors like improper handling or improper usage at user end could not be ruled out.Further investigation of the sample was not possible.Retain samples were checked for lot# and no defect related to complaint was observed.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 10FR RND DRN 1/8IN BNDBLE BLUNT 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 ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15617596
• MDR Text Key: 306514668
• Report Number: 2210968-2022-08478
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2241B
• Device Lot Number: J1920858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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