MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® P.A.S. PORT® POWER P.A.C. IMPLANTABLE ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4591-24
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that seven days after placement, a deltec® p.A.S.Port® power p.A.C.Implantable access system was unable to have blood drawn from it, and when the nurse flushed the port, extravasation was observed.An x-ray was performed and showed the port connector was broken.The port was surgically removed.The event was resolved after implanting a new port.No permanent injury was reported.
Additional Manufacturer Narrative
A deltec® p.A.S.Port® elite peripheral vascular access system with polyflow® polyurethane catheter was returned for evaluation.Visual inspection of the device showed the outlet tube did not have any weld markings about the proximal end.Based on the evidence, the complaint was confirmed.The root cause was attributed to a welding step missed in manufacturing.

• Brand Name: DELTEC® P.A.S. PORT® POWER P.A.C. 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: 6900120
• Report Number: 3012307300-2017-02080
• Device Sequence Number: 1354278
• Product Code: LJT
• UDI-Device Identifier: 10610586021565
• UDI-Public: 10610586021565
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K961580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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: Health Professional
• Device Expiration Date: 07/31/2015
• Device Catalogue Number: 21-4591-24
• Device Lot Number: 3007719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 10/30/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/10/2017
• 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
• Patient Age: 25 MO
• Patient Weight: 13