MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. PERMCATH; CATHETER, SUBCLAVIAN

Model Number	8817748001
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during dialysis, the devices venous end (blue) connector was broken (crack was observed).It was stated that the catheter was repaired and the external short tube was replaced.Flushing was done and it was when issue was observed due to oozing blood.No other defects/damages was noted than what was observed.Iodophor was the cleaning agent used to clean the adapterssame with the insertion site (disinfection) and was allowed to thoroughly dry prior to applying ointments on the area.The catheter was not repaired, there was no leak, no cleaning agent was used and tego was not utilized.No tools was used to tighten or loosen the adapter.There was no blood loss.There was no reported patient injury.
Event or Problem Description
According to the reporter, during dialysis, the devices venous end (blue) connector was broken (crack was observed).Flushing was done and it was when issue was observed due to oozing blood.No other defects/damages was noted than what was observed.Iodophor was the cleaning agent used to clean the adapters same with the insertion site (disinfection) and was allowed to thoroughly dry prior to applying ointments on the area.The catheter was not repaired, there was no leak, no cleaning agent was used and tego was not utilized.No tools was used to tighten or loosen the adapter.There was no blood loss.The device was explanted and replaced in its entirety.There was no reported patient injury.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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.

• Brand Name: PERMCATH
• Common Device Name: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• MDR Report Key: 10977832
• Report Number: 3009211636-2020-00305
• Device Sequence Number: 14535525
• Product Code: LFJ
• UDI-Device Identifier: 10884521009868
• UDI-Public: 10884521009868
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/12/2022
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 1722100105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/17/2020
• Supplement Date Received by Manufacturer: 12/07/2020
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 12/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 60