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
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the event occurred in (b(6) 2017.The exact date is unknown.
Event or Problem Description
It was reported that the tube of a port-a-cath® ii implantable access system ruptured.The port was explanted due to the rupture.No permanent injury was reported.

• Brand Name: PORT-A-CATH® II IMPLANTABLE ACCESS SYSTEM
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 7124996
• Report Number: 3012307300-2017-02660
• Device Sequence Number: 11238212
• Product Code: LJT
• UDI-Device Identifier: 10610586023552
• UDI-Public: 10610586023552
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962695
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/18/2017

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 12/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention