MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERFLOW AHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number A710962

Device Problem Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a lot history review was not performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation is inconclusive for the reported inadequate flow rate.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model a710962 implantable port allegedly experienced inadequate flow rates.This information was received from one source.The one reported malfunction involved one patient with no consequences.The age, sex and weight of the patient was not provided.

• Brand Name: POWERFLOW AHERESIS IV IMPLANTABLE PORT, CHRONOFLEX, 9.6F
• 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: 10752633
• MDR Text Key: 214168194
• Report Number: 3006260740-2020-03569
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1