MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT; IMPLANTABLE PORT

Catalog Number 1806060J

Device Problems Contamination (1120); Entrapment of Device (1212); Deformation Due to Compressive Stress (2889)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided; therefore, a lot history review was performed.The sample was returned and the investigation confirmed for entrapment of the guidewire within the needle, contamination of the guidewire with foreign material (biological), deformation of the needle tip and improper procedure or method.The root cause for the reported event was confirmed and determined to be user-related.The device was labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the powerport products that are cleared in the us.The pro code for the powerport products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 1806060j implantable port allegedly experienced unable to withdraw, entrapment of the guidewire within the needle, contamination of the guidewire with foreign material (biological), deformation of the needle tip and improper procedure or method.This information was received from one source.This malfunction involved one patient with no consequences.The patient's age, weight and gender were not provided.

• Brand Name: POWERPORT
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10295959
• MDR Text Key: 199505728
• Report Number: 3006260740-2020-02576
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741111624
• UDI-Public: (01)00801741111624
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1806060J
• Device Lot Number: REDR2938
• Date Manufacturer Received: 06/30/2020
• Type of Device Usage: Initial
• Patient Sequence Number: 1