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

Model Number A710962

Device Problems Restricted Flow rate (1248); Fluid/Blood Leak (1250); Failure to Infuse (2340); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon 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 apheresis port allegedly experienced restricted flow rate, failure to infuse, and port rotation.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.

Manufacturer Narrative

H10: as the lot number for the devices were not provided, a manufacturing review could not be performed.The devices were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.Gray, k.L., steidley, i.G., benson, h.L., pearce, c.L., bachman, a.M., & adamski, j.(2019).Implementation and 2-year outcomes of the first fda-approved implantable apheresis vascular access device.Transfusion, 59(11):3461-3467.Doi: 10.1111/trf.15512.H10: g3.H11: b5, g1, h6(conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes five malfunctions.A review of the reported information indicated that model a710962 apheresis port allegedly experienced restricted flow rate, failure to infuse, and port rotation.This information was received from one source.The malfunctions involved patients with no consequences.The patient's age, weight and gender were not provided.

• Brand Name: POWERFLOW 16G IV PORT INTER
• Type of Device: APHERESIS 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: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 9602297
• MDR Text Key: 193307085
• Report Number: 3006260740-2020-00216
• 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,Followup
• Report Date: 07/22/2022

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 Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2022
• Type of Device Usage: A
• Patient Sequence Number: 1