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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/29/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of aseqf029 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (aseqf029) have been reported from the same facility.
 
Event Description
It was reported an ma from blood draw had the safety on a needle not engage after using on a patient. Additional information stated: "the ma was deaccessing the needle and the safety did not engage. The ma removed it from the patient¿s chest and the needle ¿bounced¿ back. There was not a needle stick injury".
 
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Brand NamePOWERLOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
Type of DeviceSET, 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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key10434121
MDR Text Key204048638
Report Number3006260740-2020-02972
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial
Report Date 08/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0672034
Device Lot NumberASEQF029
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/29/2020
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

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