MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 13F X 15CM DUO-FLOW III CURVED; DUO-FLOW III STEP TIP CATHETER

Model Number DFST136CEE

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/21/2023

Event Type  malfunction  

Event Description

The venous connection dislocated during treatment between tube and venous connection.

Manufacturer Narrative

An investigation has been initiated.We are currently waiting for additional information and the return of the device 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 device involved in this incident was not returned for evaluation and no further information regarding the incident was provided.One photograph of the device involved was provided.The photo shows a catheter that had obviously been implanted because it was discolored and bloody.The proximal end of the venous extension tubing appears to have been cleanly cut through, the edges of the cut are smooth.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured and inspected according to specification with no non-conformances or abnormalities.The device is handled and inspected multiple times during manufacturing and inspection.Any damage to the extension that could lead to this type of failure would be noted and the device would be discarded.Without an evaluation of the device a root cause cannot be determined; however, it is unlikely to be related to manufacturing.The instructions for use (ifu) contains the following warnings and precautions that are potential causes for extension failure.*do not use sharp instruments near the extension tubing or catheter lumen.*do not use scissors to remove dressing.*catheter will be damaged if clamps other than what is provided with this kit are used.*clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.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: 13F X 15CM DUO-FLOW III CURVED
• Type of Device: DUO-FLOW III STEP TIP CATHETER
• 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: 18474234
• MDR Text Key: 332425192
• Report Number: 2518902-2024-00004
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

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: DFST136CEE
• Device Catalogue Number: DFST136CEE
• Device Lot Number: MQRV370
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 01/03/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention