MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. P.A.S. PORT® ELITE PERIPHERAL VASCULAR ACCESS SYSTEMS WITH POLYFLOW® POLYURETHAN; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4591-24
Medical Device Problem Codes	Material Fragmentation (1261); Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a 10 cm portion of a smiths medical port tube was pulled out upon removal of the system.The point of rupture was reported to be yellowish, both ends of the device are feathered and torn.Additionally, the material has been reported to be porous.The remaining 10 cm long part was recovered angiographically.No further adverse effects reported.

• Brand Name: P.A.S. PORT® ELITE PERIPHERAL VASCULAR ACCESS SYSTEMS WITH POLYFLOW® POLYURETHAN
• 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: 8879167
• Report Number: 3012307300-2019-04032
• Device Sequence Number: 19384641
• Product Code: LJT
• UDI-Device Identifier: 10610586021565
• UDI-Public: 10610586021565
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K961580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2019

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: 03/01/2017
• Device Catalogue Number: 21-4591-24
• Device Lot Number: 2249691
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 08/09/2019
• 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