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 01/20/2022

Event Type  malfunction  

Event Description

It was reported a patient underwent a total hip arthroplasty (b)(6) 2022 and a drain was used.Air leak may have occurred, and it was not functioning, so they guessed it was due to the drain.Drain was removed.Suction could be done properly after the drain was replaced.Further details are not provided.There were no adverse consequences to the patient.No additional incision was made for the patient when the drain was replaced.The patient's condition is fine.It is possible that the needle damaged the product when it was sutured to fix the skin, but the doctor in charge did not intend to stab the product.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and obtained.Attempts to obtain the device however not received.If further details are received at a later date a supplemental medwatch will be sent.No additional incision was made for the patient when the drain was replaced.The patient's condition is fine.It is possible that the needle damaged the product when it was sutured to fix the skin, but the doctor in charge did not intend to stab the product.What are the product codes and lot numbers of the two reservoirs which were used prior to noticing the issue was the blake drain? the product code is 2179.The lot number is j1921392.Was a third reservoir used once the drain was replaced? or did they use one of the two reservoirs which were already opened? no further information is available.Please clarify, how many drains will be returned for evaluation? one drain that belongs to one reservoir will be returning.The product code is 2179 and the lot number is ju0417.Only 1 reservoir will be returned, not 2.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Component code: g07002 reported condition not confirmed.H3 evaluation: one used sample of drain was received for evaluation.During evaluation, system test was performed on complaint sample received to check the suction process of drain sample.No discrepancy found in suction test.Moreoveer no blockage found in the drain sample received.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 SHARP TR
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA SILICON LTD.-INDIA; 251, sector-6, imt; manesar ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13608051
• MDR Text Key: 287407076
• Report Number: 2210968-2022-01329
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 2225S
• Device Lot Number: J1921392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/26/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1