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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 20G X .0.75"; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS HUBER PLUS 20G X .0.75"; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional 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.
 
Event or Problem Description
It was reported that when attempting to attach the needleless connector to the end of the tubing, the tubing/connection was cracked.It is stated that no force was used to tighten the connection.It was reported that this happened two times on the same patient requiring reaccess.This report addresses the second device used.
 
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Brand Name
HUBER PLUS 20G X .0.75"
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8189521
Report Number3006260740-2018-03678
Device Sequence Number11259422
Product Code FPA
UDI-Device Identifier00801741065620
UDI-Public(01)00801741065620
Combination Product (Y/N)N
Initial Reporter StateCT
Initial Reporter CountryUS
PMA/510(K) Number
K993848
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/20/2018
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 Model NumberN/A
Device Catalogue Number012034
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/06/2018
Initial Report FDA Received Date12/21/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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