MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. CATHETER, PERITONEAL, LONG-TERM INM CATHETER, PERITONEAL, LONG-TERM INDWELLING

Model Number UNK DY

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, when the catheter was being removed because it was falling out of the patient, they noticed the bubbling on the catheter's shaft.There was no reported patient outcome.

Manufacturer Narrative

This device has been reported as a general medtronic dialysis product, but no further information was provided.A variety of fda product codes are associated with this group of products, and the specific code cannot be identified with the information available.The most common fda product code for this type of device has been added to the product information within this report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Because no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed.However, all dhrs are reviewed for accuracy prior to product release.The physical sample involved in the reported incident was not returned for evaluation.Three photos were provided by the customer.Visual evaluations of these photos were performed and were observed the section of them has bubbles or blistering in the am sleeve.The reported condition was confirmed with the photos provided by the customer.Based on the available information could not be attributing to manufacturing process; the most probable root cause can be considered as that the customer used a different cleaning agent from recommended.No further actions are required.This complaint will be used for tracking and trending purposes.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during use, the catheter was dislodged and fell out.And they noticed the bubbling on the catheter¿s shaft.A new catheter was inserted and there was no patient injury.

• Brand Name: CATHETER, PERITONEAL, LONG-TERM INM CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Type of Device: CATHETER, PERITONEAL, LONG-TERM INDWELLING
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7560272
• MDR Text Key: 111891716
• Report Number: 3009211636-2018-00166
• Device Sequence Number: 1
• Product Code: FJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2019

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: UNK DY
• Device Catalogue Number: UNK DY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Initial Date Manufacturer Received: 05/16/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 05/16/2018; 01/09/2019
• Supplement Dates FDA Received: 06/20/2018; 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1