MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 19FR R/F; CATHETER, IRRIGATION

Model Number 2232

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

It was reported a patient underwent an unknown procedure on an unknown date and a drain was used.Air inclusion occurred, leakage.Further details are not provided.There were no adverse consequences to the patient.

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.We do not understand what air inclusion means.What was the issue with the drain? there was air in the connector part of the drain.Was their an "air leak"? no further information is available.Is there a visible flaw or damage to the drain? no further information is available.How many drains were used during surgery on this patient? the sales rep reported that multiple packages were opened, and the same issue was confirmed in each product.No further information is available.How many were opened outside of surgery? no further information is available.No further information will be provided.Multiple packages were opened, and the same issue was observed in each product.Air inclusion was occurred at the connector part.When was the air inclusion occurred (in the package, during removal from package, during handling or during use on the patient)? please specify 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.Could you please confirm the quantity of drains with air inclusions? qty of product involved is 10.Did the event occur during one or multiple patient procedures? multiple packages were opened and the same issue was confirmed in each product.And this issue was reported as one complaint.No further information is available.If the event occurred in multiple patient procedures, what is the total number of procedures? no further information will be provided.Have any of these events been previously reported to ethicon? no further information will be provided.If so, provide the respective reference number(s): no further information will be provided.If not, please create a case (pc #) for every procedure: no further information will be provided.Device return status: we regularly contact with sales rep about the device returning.No further information will be provided.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Note: events reported on mw# 2210968-2021-12560, mw# 2210968-2021-12561, mw# 2210968-2021-12562, mw# 2210968-2021-12564, mw# 2210968-2021-12565, mw# 2210968-2021-12566, mw# 2210968-2021-12567, mw# 2210968-2021-12568, mw# 2210968-2021-12569.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).Additional information: d9, h6 component code: g07002 reported condition not confirmed.H3 evaluation: retain sample of the same lot was checked and found within the specified criteria.Samples received (3) unopened and samples again received (7) opened for investigation for evaluation of lot packed samples were checked and found intact.No air inclusion (occlusion) 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 (R) DRAIN 19FR R/F
• 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 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13000674
• MDR Text Key: 288388325
• Report Number: 2210968-2021-12563
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003606
• UDI-Public: 10705031003606
• 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: 02/14/2022

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 Model Number: 2232
• Device Catalogue Number: 2232
• Device Lot Number: J2107475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2021
• Initial Date FDA Received: 12/14/2021
• Supplement Dates Manufacturer Received: 01/18/2022
• Supplement Dates FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1