MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. DUO-FLOW; DUO-FLOW IJ

Model Number	XTP118IJSE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2020
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
Catheter was noted to be leaking a few drops of blood at the connection of the arterial extension, and the hub.Catheter was exchanged immediately.
Additional Manufacturer Narrative
The pre-curved duo-flow catheter was received for evaluation.A visual examination of the device revealed no obvious damage to the device, however there is no printing on the hub and some of the printing on the id tags is missing.A functional test of the device revealed a hole in the tubing of the red extension at the hub joint.The hole is only visible when the tubing is bent away from the hub.A supplier corrective action request was issued to the contract manufacturer.The contract manufacturer conducted an evaluation of the device, as well as a review of the manufacture records for the lot number reported.Their investigation also confirmed the complaint as a leak was noted where the hub and extension line connect.The information printed on the id rings of the device were also degraded.A review of the manufacture records revealed the device was manufactured according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test of the finished product.This test would have detected such a leak if it had occurred during the manufacture process.The device was reported to be implanted for 10 days prior to the reported event.A definitive root cause cannot be determined but is most likely not 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 avail able for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: DUO-FLOW
• Common Device Name: DUO-FLOW IJ
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10721759
• Report Number: 2518902-2020-00050
• Device Sequence Number: 3025657
• Product Code: MPB
• UDI-Device Identifier: 00884908059786
• UDI-Public: 884908059786
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K983511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2020

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 Expiration Date: 04/17/2024
• Device Model Number: XTP118IJSE
• Device Catalogue Number: XTP118IJSE
• Device Lot Number: MMBC350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• 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: 12/28/2020
• 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: 62 YR