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	Blood Loss (2597)
Date of Event	12/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.
Event or Problem Description
During dialysis it was noted that patient was bleeding from the insertion site.Patient lost two (2) units of blood.Catheter was removed and it was noted that there was a hole between the lumens.
Additional Manufacturer Narrative
The contract manufacturer evaluated the returned device and reviewed the manufacture records.The review of the manufacture records shows the device was manufactured according to specification.The device was also 100% leak tested after manufacture.Samples were used to attempt to reproduce the issue.The only test of the samples that produced a similar slit in the lumen was the use of a scalpel.Based on the evaluation of the returned device and the review of the manufacture records it was determined that the root cause of this issue cannot be determined but is deemed not manufacturing related.The instructions for use (ifu) included the following catheter precautions: "do not use sharp instruments near the extension tubing or catheter lumen." and "do not use scissors to remove dressing.".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.

• 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: 9621435
• Report Number: 2518902-2020-00002
• Device Sequence Number: 547686
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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
• Patient Age: 14 YR