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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Defective Component (2292)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event or Problem Description
It was reported the bard powerloc swis y-site cap was loose and fell off on one patient.It was stated this poses an infection risk and safety risk.
 
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Brand Name
POWERLOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10373000
Report Number3006260740-2020-02807
Device Sequence Number2476548
Product Code FPA
UDI-Device Identifier00801741047916
UDI-Public(01)00801741047916
Combination Product (Y/N)N
Initial Reporter StateND
Initial Reporter CountryUS
PMA/510(K) Number
K060812
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 08/06/2020
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? Yes
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue Number0671934
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/14/2020
Initial Report FDA Received Date08/06/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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