MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Catalog Number 2217

Device Problem Leak/Splash (1354)

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

Event Date 02/05/2024

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Additional information: h6 component code: g07002 - device not returned.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? unk.Was leakage detected? unk.Did the drain come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time?¿no report with contact with surgical instrument.Was the drain broken into two or more pieces?¿yes.Did this issue contribute to any patient adverse event?¿fortunately, not be left patient body, but the additional x-ray test was performed.Please perform and document the follow up attempt for product return.We will ship soon.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 by a sales rep that, during a pancreaticoduodenectomy : pd, one product was used on the back of the pancreaticojejunostomy.Four days later, it was found that the joint of the product was almost shredded.Fortunately, the surgeon managed to take the product because it was slightly stuck on the surface of the body.It was managed during the day with ikemaze pochette.[the patient demographics] 80 year old man.[current status of the patient] the patient is in the hospital.[treatment details] once the drain was removed, x-rays were taken to check for residuals in the body.Further details are not provided from the hp.When we send the sample to you, we will let you know its return date and tracking number.Affiliate reference number is (b)(4).

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.The broken drain has nothing to do with a reservoir.Yes.What is the issue reported with the reservoir.No complaint with the reservoir.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: complaint sample review : one complaint samples of drain, with separated flat portion was received for evaluation, both the portions were inspected visually, below were detailed observations: 1.Drain was cut-off in two portions from the hub area.2.Separation ends of round drain and flat drain were inspected under magnification, and found that there were deep cut marks present.3.Small piece from hub area was also found separated.Documents review : batch manufacturing record review is not performed, as the lot no of complaint is unknown.Retention sample review : retention sample is not checked, as the lot no of complaint is unknown.It is suspected that, external factors like mishandling or improper usage at user end could not be ruled out.As per standard practice, 100% functional test was performed on the product.Also, 100% visual inspection was carried out visually before and after packing of finished goods, prior to the product release.There was no scope to miss such defect, at manufacturing / release stage.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 inc, or its employees that the report constitutes an admission that the product, ethicon inc, 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 10MM FLAT 3/4 FLUTED W/ 3/16IN 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 12205 2; IN 122052
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18791154
• MDR Text Key: 337464271
• Report Number: 2210968-2024-01992
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• 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,Followup
• Report Date: 05/22/2024

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: 2217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 02/28/2024; 05/15/2024
• Supplement Dates FDA Received: 03/19/2024; 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 80 YR
• Patient Sex: Male