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

Model Number	8817748001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/03/2019
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 use, leakage from the exit site was observed at the junction of the hub and the catheter shaft.The catheter was explanted and replaced with a similar catheter, no leakage observed in the replacement catheter.It was also stated that the catheter was not repaired, there was no luer adapter issue, and tego was not utilized, no other devices were utilized by the device, there were no other defects or damages found on the product where the leak was observed.There was blood loss of 5ml as a result of the event.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection noted: the catheter appeared intact.A functional evaluation found that the catheter was submerged into a water bath.The ends were clamped, and a syringe was used to inject air to observe leakage.Air bubbles were present at the distal end of the cannula.A small hole was observed.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.If information is provided in the future, a supplemental report will be issued.

• 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: 8300595
• Report Number: 3009211636-2019-00020
• Device Sequence Number: 11028834
• Product Code: LFJ
• UDI-Device Identifier: 10884521009868
• UDI-Public: 10884521009868
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K871942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2021
• Device Model Number: 8817748001
• Device Catalogue Number: 8817748001
• Device Lot Number: 1613200088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Initial Date Received by Manufacturer: 01/11/2019
• Supplement Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 02/03/2019
• Supplement Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1