MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERFLOW 16G IV PORT INTER; IMPLANTABLE PORT

Model Number A710962

Device Problem Failure to Infuse (2340)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was not provided, therefore a lot history review could not be performed.The device was not returned for evaluation, therefore, the investigation is inconclusive as no objective evidence was provided.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This event summarizes one malfunction.A review of the reported information indicates that model a710962 implantable port allegedly experienced failure to infuse.The information was received from a single source.The malfunction involved one patient with no patient injury.The female patient's age and weight were not provided.

• Brand Name: POWERFLOW 16G IV PORT INTER
• 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: 9601996
• MDR Text Key: 192166766
• Report Number: 3006260740-2020-00211
• Device Sequence Number: 1
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438
• 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: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/31/2019
• Type of Device Usage: N
• Patient Sequence Number: 1