MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F X 18CM HEMO-CATH; HEMO-CATH LT

Model Number	SL18P
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.Currently waiting for the return of the device sample for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Communication problem between the arterial way and venous way of the catheter.Opacification made to confirm intraluminal communication between the two vascular pathways of the catheter.Circumstances of the occurrence are not known.
Additional Manufacturer Narrative
The hemo-cath was returned for evaluation in two pieces.The lumen was cut at the hub and a small piece of the lumen approximately 7 cm in length was returned.No id rings were present on either extension line.When flushed through the venous luer the fluid exits the venous lumen, when flushed through the arterial luer the fluid exits the arterial lumen.The condition of the returned device is not sufficient for further testing and evaluation.The contract manufacturer conducted a review of the manufacture records for the lot number taken from the returned device.Their investigation revealed the device was manufactured according to specification with no non-conformances or abnormalities.The device was implanted for two and half years with no reported issues.A root cause cannot be determined but is not likely manufacture related.Based on historic data this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 8F X 18CM HEMO-CATH
• Common Device Name: HEMO-CATH LT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11304414
• Report Number: 2518902-2021-00007
• Device Sequence Number: 11969630
• Product Code: MSD
• UDI-Device Identifier: 00884908045444
• UDI-Public: 884908045444
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2021

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?: No
• Operator of Device: Other
• Device Model Number: SL18P
• Device Catalogue Number: SL18P
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 02/09/2021
• Supplement Report FDA Received Date: 04/08/2021
• 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 Weight: 13