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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PFLEX, 20G 8CM BASIC KIT (POWERGLIDE PRO); INTRAVASCULAR CATHETER
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BARD ACCESS SYSTEMS PFLEX, 20G 8CM BASIC KIT (POWERGLIDE PRO); INTRAVASCULAR CATHETER Back to Search Results
Catalog Number F120080
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not yet returned for evaluation.
 
Event or Problem Description
11/04/2016- per sales representative, the facility reported a sheared catheter.No patient harm reported.
 
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Brand Name
PFLEX, 20G 8CM BASIC KIT (POWERGLIDE PRO)
Common Device Name
INTRAVASCULAR CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key6120648
Report Number3006260740-2016-00625
Device Sequence Number358074
Product Code FOZ
UDI-Device Identifier00801741110528
UDI-Public(01)00801741110528
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
K153280
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Health Professional
Type of Report Initial
Report Date (Section B) 11/03/2016
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 Catalogue NumberF120080
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/22/2016
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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