MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX24CM HEMO-CATH; HEMO-CATH HEMODIALYSIS CATHETER

Model Number	MC101243
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
During a contrast study, a hole in the line was detected.
Additional Manufacturer Narrative
The hemo-cath catheter was returned for evaluation.Visual inspection confirmed a small pinhole leak on the lumen approximately 9.5 cm from the hub.The hole appears to be a puncture with a small sharp object such as a needle.The description provided states the issue was detected during a contrast study.The instructions for use (ifu) states that this device is indicated for use in attaining long-term vascular access for hemodialysis and apheresis only.This device is not indicated for use in contrast studies.As such, the use for contrast study is off label.It cannot be determined what may have caused the pinhole.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test of all catheters prior to packaging.This test would have detected any holes or leaks that may have occurred during the manufacture process.A definitive root cause cannot be determined but it is considered to not be related to the manufacture process.

• Brand Name: 12.5FX24CM HEMO-CATH
• Common Device Name: HEMO-CATH HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10721933
• Report Number: 2518902-2020-00051
• Device Sequence Number: 14299198
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2020

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: Other
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 12/17/2020
• 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: Required Intervention