MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number	8888135162
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.Visual inspection noted the image depicts the suture wing attached to a patient.It was reported that there was a securement wing issue.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, when the patient¿s head was turned during dialysis treatment, the securement wing was still attached to the skin via suture and the stiches were still holding but the catheter was dislodged from the securement wing.It was stated that the catheter was not migrated from the patient's body.Catheter was not used despite the issue, instead, a new catheter was reinserted to complete the procedure.Flushing was done prior to use of the device and has no blockage.It was stated that the ring of the suture wing was not broken and no unnecessary movements or anything happened that might have contributed on the event.Steri prep was the cleaning agent used on the device and on the insertion site.Tego was utilized.There was no blood loss.The catheter was not repaired, there was no leak and no luer adapter issue.There was no damage or defects noted on the catheter and nothing unusual observed on the device prior to use.No other products being utilized on the device prior to use.There was no patient injury.

• Brand Name: MAHURKAR
• Common Device Name: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CR 20101
• MDR Report Key: 10738125
• Report Number: 3009211636-2020-00261
• Device Sequence Number: 4246873
• Product Code: MPB
• UDI-Device Identifier: 10884521006379
• UDI-Public: 10884521006379
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K030209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 09/04/2024
• Device Model Number: 8888135162
• Device Catalogue Number: 8888135162
• Device Lot Number: 1926800456
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2020
• Initial Report FDA Received Date: 10/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1