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

Catalog Number 2225S

Device Problem Leak/Splash (1354)

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

Event Date 09/21/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.What is the lot number? no further information is available.Was the drain broken into two or more pieces? no further information is available.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.Was a new drain needed to correct the situation? if yes, was the new drain placed surgically? no further information is available.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 Description

It was reported a patient underwent an unknown spine procedure on (b)(6) 2022 and a drain was used.During procedure, it was found that the drain was broken and blood was leaking.The surgery was completed with replacement of the drain.No sample will be returned.There were no adverse consequences to the patient.

• Brand Name: BLAKE 10FR RND DRN 1/8IN BNDBLE SHARP 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: 15546562
• MDR Text Key: 306453248
• Report Number: 2210968-2022-08234
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2225S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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