MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Failure to Deliver (2338); Detachment of Device or Device Component (2907)

Patient Problem Hypoglycemia (1912)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.(b)(4).

Event Description

It was reported via medwatch, "the patient had a power port that was accessed in the ed prior to the ct scan.The radiology nurse flushed the port and had noted blood return prior to hooking up the power injector to inject the contrast.During the injection the cap came off the port and resulted in the contrast not getting delivered into the patient.The patient was injected by hand with the contrast and scanned.".

• Brand Name: POWERLOC SAFETY INFUSION SET 20G X 1 IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 8997567
• MDR Text Key: 163165707
• Report Number: 3006260740-2019-02638
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741047923
• UDI-Public: (01)00801741047923
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060812
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0672010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1