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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 19G X 19MM; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS EZ HUBER 19G X 19MM; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number SHG19-75
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 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 that the huber needle was removed in the correct manner and the needle came detached from the hub, the needle remained in patients port.
 
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Brand Name
EZ HUBER 19G X 19MM
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7793400
Report Number3006260740-2018-02121
Device Sequence Number1249623
Product Code FPA
UDI-Device Identifier00801741089138
UDI-Public(01)00801741089138
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K071846
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/17/2018
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 NumberSHG19-75
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 Date08/17/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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