MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 8F PRO-FUSE CT PLAST PORT; PRO-FUSE CT PORT

Model Number MRCTT80001

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Pain (1994)

Event Type  malfunction  

Event Description

Port lumen leaked approximately 5 cm from the port stem.

Manufacturer Narrative

We are currently waiting for the device to be returned 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.

Manufacturer Narrative

The 8f pro-fuse port was returned for evaluation.A 22cm segment of lumen is attached to the port stem with a catheter lock.Visual examination of the lumen shows a longitudinal slice in the lumen 6.5cm from the port stem.The slice is 0.5cm in length.The slice leaks when the device is flushed.There is another mark on the lumen perpendicular to the slice.This mark does not leak.A supplier corrective action request was issued to the contract manufacturer for this event.The visual inspection identified two areas of damage to the lumen.The first area presented two perpendicular marks, approximately 0.5 cm long.Of these 2 marks, the lower mark is where the leak was present.The marks/lines appear to have been made by something that pressed this section of the tube, causing these marks to be generated and later the leakage.The second area of damage looks like the tube was twisted, causing this deformation with no leak.A review of the manufacture records for the lot number reported revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The device was implanted and functioned with no issues for one month prior to the reported event.Based on the evaluation of the device and a review of the manufacture records a root cause cannot be determined but is not likely manufacture related.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 PRO-FUSE CT PLAST PORT
• Type of Device: PRO-FUSE CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 17964545
• MDR Text Key: 326022573
• Report Number: 2518902-2023-00066
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908031379
• UDI-Public: 00884908031379
• Combination Product (y/n): N
• Reporter Country Code: NP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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
• Device Operator: Other
• Device Model Number: MRCTT80001
• Device Catalogue Number: MRCTT80001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 10/13/2023
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG