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

Model Number	8834369001
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
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 use, the catheter was corrupted in the patients pleura region.There was leak in the intra pleural.Chlorhexidine was used as a cleaning agent.A medical intervention was done to relocate the catheter and implant another.The patient extended their hospitalization.
Event or Problem Description
According to the reporter, during use, the catheter was corrupted in the patients pleura region.There was a leak in the intra pleura.It was stated that the insertion site was via intra-atrial thoracotomy.Chlorhexidine was used as a cleaning agent.A medical intervention was done to relocate the catheter and implant another and patient was injected with electrolyte solution.The hemodialysis treatment was delayed.The patient hospitalization was extended.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led a photographic evaluation of one device.Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition.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.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 or Problem Description
According to the reporter, during use, the catheter was corrupted/broke in the patients pleura region.There was a leak in the intra pleura.It was stated that the insertion site was via intra-atrial thoracotomy.Chlorhexidine was used as a cleaning agent.A medical intervention was done to relocate the catheter and implant another and patient was injected with electrolyte solution.The catheter was replaced.The hemodialysis treatment was delayed.The patient hospitalization was extended.There was no reported patient injury.

• Brand Name: PERMCATH
• Common Device Name: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 8386789
• Report Number: 3009211636-2019-00054
• Device Sequence Number: 1795015
• Product Code: LFJ
• UDI-Device Identifier: 20884521009902
• UDI-Public: 20884521009902
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K871942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8834369001
• Device Catalogue Number: 8834369001
• Device Lot Number: 1724900137
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2019
• Supplement Date Received by Manufacturer: 02/18/2019; 05/06/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/19/2019; 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 28