MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F DIGNITY CT PORT

Model Number MRDP50AXS

Device Problem Component Incompatible (1108)

Patient Problem Thrombosis (2100)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

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 Description

The device was being used for an arm insertion.After gaining access, positioning the catheter, and removing the peel-away sheath, it was discovered that the port stem was not compatible with the f size of the catheter.

Manufacturer Narrative

The customer returned one un-opened kit from the same lot.A visual examination of the port lumen and port was performed.The port stem is too large.The lumen cannot be attached to the port stem.The lot number on the port base corresponds to the port base for a 6.6f port.The 5f lumen cannot be attached to the port stem.A supplier corrective action request was issued to the contract manufacturer.Their investigation revealed the root cause was failure to properly follow procedures when pulling components for packaging.The written procedures will be updated to enhance the escalation process for quantity discrepancies.Physical locations in the warehouse will be established for the port families.The procedure for delivery to the production team will be updated to include material, lot number, and quantity received to be included in the work order.The implementation of a bar code system for taking materials from the warehouse will also be proposed.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: 5F DIGNITY CT PORT
• Type of Device: DIGNITY CT PORT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 10934429
• MDR Text Key: 219372358
• Report Number: 2518902-2020-00059
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00884908149753
• UDI-Public: 884908149753
• Combination Product (y/n): N
• PMA/PMN Number: K132177
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MRDP50AXS
• Device Catalogue Number: MRDP50AXS
• Device Lot Number: MPDX180
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention