MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERFLOW 16G IV PORT INTER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number A710962

Device Problems Complete Blockage (1094); Suction Problem (2170); 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 provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.(expiry date: 09/2019).

Event Description

It was reported that during the port placement a piece of tissue allegedly passed through the valve and the port could not be aspirated.Reportedly, the device was removed and replaced.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one powerflow port body and an iv adaptor were returned for evaluation.Functional, gross visual and microscopic visual evaluations were performed.The investigation is confirmed for an occlusion in the port body, as the sample was occluded before and after decontamination but with increased hydraulic effort some residue was ejected through/from the valve.The port was patent to infusion and aspiration and no leaks were observed after the residue had been ejected.Upon visual inspection, the ejected residue appeared to be dried blood which crumbled under slight pressure.The returned sample had blood and fluid residue throughout the device.The definitive root cause could not be determined based upon available information.It is unknown if procedural and/or manufacturing issues contributed to the reported event.Labeling review: the cause of the event in question is unknown, and so the applicability of any particular portion of the instructions for use (ifu) or other labeling is unknown.However, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the ifu instructs on port placement and on accessing the port, and therefore the product labeling will be considered adequate.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

It was reported that during the port placement a piece of tissue allegedly passed through the valve and the port could not be aspirated.Reportedly, the device was removed and replaced.There was no reported patient injury.

• Brand Name: POWERFLOW 16G IV PORT INTER
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8750496
• MDR Text Key: 149774301
• Report Number: 3006260740-2019-01842
• Device Sequence Number: 1
• Product Code: PTD
• UDI-Device Identifier: 00801741129438
• UDI-Public: (01)00801741129438
• Combination Product (y/n): N
• PMA/PMN Number: K163001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A710962
• Device Catalogue Number: A710962
• Device Lot Number: REDP0143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2019
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1