MAUDE Adverse Event Report: ST PAUL DELTEC PORT-A-CATH POWER P.A.C; PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVA

Model Number 21-4425-24

Device Problem Material Puncture/Hole (1504)

Patient Problem Pneumonia (2011)

Event Date 01/14/2022

Event Type  Injury  

Event Description

It was reported that a patient was injured - extravasation event relating to port-a-cath.Port-a-cath removed, small hole halfway along the length of the portacath line.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).No problems or issues were identified during this device history record review.No product sample was received; therefore, visual and functional testing could not be performed.No serial number was provided.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: DELTEC PORT-A-CATH POWER P.A.C
• Type of Device: PORT CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVA
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 494 rosebank road; minneapolis, MN 55442
• MDR Report Key: 14219506
• MDR Text Key: 290164210
• Report Number: 3012307300-2022-06980
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032646
• UDI-Public: 10610586032646
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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: Health Professional
• Device Model Number: 21-4425-24
• Device Catalogue Number: 21-4425-24
• Device Lot Number: 3999309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 04/14/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention