MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 5676300

Device Problems Component Incompatible (1108); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was returned and a lot history review was performed.The device was returned for evaluation and missing component was confirmed.The cause of this is manufacturing related.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5676300 port and catheter allegedly experienced incompatible component and missing components.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.

• Brand Name: POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• 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: 9211268
• MDR Text Key: 164291330
• Report Number: 3006260740-2019-03203
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741110771
• UDI-Public: (01)00801741110771
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5676300
• Device Catalogue Number: 5676300
• Device Lot Number: RECX3530
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1