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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 12/04/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascrs0127 showed no other similar product complaint(s) from this lot number.
 
Event or Problem Description
It was reported that the huber's needle (cannula for puncture reservoir 0.90x25mm 20g) after use, the safety device did not allow to be triggered.No other information provided.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 20G X 1 IN
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8615650
Report Number3006260740-2019-01397
Device Sequence Number13996469
Product Code FPA
UDI-Device Identifier00801741066221
UDI-Public(01)00801741066221
Combination Product (Y/N)N
Initial Reporter CountryBR
PMA/510(K) Number
K153440
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source consumer,other
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 05/16/2019
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 Expiration Date03/28/2021
Device Model NumberN/A
Device Catalogue NumberLH-0032
Device Lot NumberASCRS0127
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/22/2019
Initial Report FDA Received Date05/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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