MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORT-A-CATH® II IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 21-4055-24

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

It was reported that the event occurred in (b)(6) 2017.The exact date is unknown.(b)(6).

Event Description

It was reported that the "wound of pocket" of a port-a-cath® ii implantable access system wouldn't heal.The patient is still under treatment.

• Brand Name: PORT-A-CATH® II IMPLANTABLE ACCESS SYSTEM
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD INC.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7126677
• MDR Text Key: 95161316
• Report Number: 3012307300-2017-02625
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586023552
• UDI-Public: 10610586023552
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962695
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 21-4055-24
• Device Lot Number: 3259009
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY
• Patient Outcome(s): Required Intervention