MAUDE Adverse Event Report: ST PAUL PORT-A-CATH IMPLANTABLE ACCESS SYSTEM; PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV

Catalog Number 21-4455-24

Device Problems Break (1069); Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 07/13/2023

Event Type  Injury  

Event Description

It was reported that a patient was sent to have the device removed due to it breaking.The device was implanted (b)(6) 2023 and recently developed an "issue".Adverse patient effects are unknown.

Manufacturer Narrative

Other text: d4: lot number, expiration date and h4: device manufacture date is unknown, no information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

• Brand Name: PORT-A-CATH IMPLANTABLE ACCESS SYSTEM
• Type of Device: PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAV
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17616190
• MDR Text Key: 321879291
• Report Number: 3012307300-2023-08390
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586032707
• UDI-Public: 10610586032707
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K072657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/24/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 21-4455-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/24/2023
• 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 Outcome(s): Required Intervention