MAUDE Adverse Event Report: ST PAUL DELTEC POWER PORT-A-CATH II PORTS; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS

Model Number 21-8466-24

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Other text: e4 is unknown.This mdr was generated under protocol (b)(4), as a result of warning letter (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.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.

Event Description

It was reported that the device seal was defective and medication was leaking.No patient injury was reported.

• Brand Name: DELTEC POWER PORT-A-CATH II PORTS
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16918593
• MDR Text Key: 315078832
• Report Number: 3012307300-2023-05637
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032837
• UDI-Public: 10610586032837
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-8466-24
• Device Catalogue Number: 21-8466-24
• Device Lot Number: 4073118
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Sex: Male