MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SINGLE-LUMEN LOW PROFILE PORTAL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4183-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluation: one smiths medical single-lumen low profile portal was returned for analysis in used condition without its original packaging.Visual inspection showed numerous scratches on the surface of the insert and the housing bottom surface.Functional testing involved leak testing and showed the device was leaking from the insert.A review of manufacturing processes was performed.It was verified that procedures in the assembly process and quality check process were being properly followed.While no definitive problem source to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a cause of issue related to manufacturing.The investigation determined a possible, but unconfirmed, source of the reported issue to be that it became damaged after leaving smiths medical.Based on evidence and investigation, the complaint allegation was confirmed; however, the problem source could not be identified.Additional reporter information: (b)(6).Report source: foreign country: (b)(6).
Event or Problem Description
Information was received indicating that a patient experienced extravasation during the use of a smiths medical single-lumen low profile portal.It was reported that an angiography with contrast medium was performed and that the catheter was subsequently replaced.Per reporter after its removal and on review, the portal was found to be leaking from the base of the catheter port.No additional adverse patient effects were reported.

• Brand Name: SINGLE-LUMEN LOW PROFILE PORTAL
• 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: 9153078
• Report Number: 3012307300-2019-05354
• Device Sequence Number: 11458631
• Product Code: LJT
• UDI-Device Identifier: 10610586012778
• UDI-Public: 10610586012778
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2022
• Device Catalogue Number: 21-4183-24
• Device Lot Number: 87X251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 10/03/2019
• 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