MAUDE Adverse Event Report: ST PAUL DELTEC; PORT-A-CATH II PORTS

Model Number 21-4083-24

Device Problem Sharp Edges (4013)

Patient Problem No Information (3190)

Event Date 07/30/2020

Event Type  malfunction  

Event Description

It was reported that while in use, the tip of the infusion needle has a barb.No adverse effects reported.

• Brand Name: DELTEC
• Type of Device: PORT-A-CATH II PORTS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10489701
• MDR Text Key: 205550911
• Report Number: 3012307300-2020-09033
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586023613
• UDI-Public: 10610586023613
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K942024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 21-4083-24
• Device Catalogue Number: 21-4083-24
• Device Lot Number: 3829675
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1