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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 19G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Medical Device Problem Code Activation Problem (4042)
Health Effect - Clinical Codes Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event 06/17/2020
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 the needle was removed from the implantable venous device, the needle did not retract.Remained stuck on the dressing is when the nurse wanted to take it off that she pricked herself.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 19G X 0.75IN
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10258892
Report Number3006260740-2020-02390
Device Sequence Number19561213
Product Code FPA
UDI-Device Identifier00801741066245
UDI-Public(01)00801741066245
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K153440
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 07/10/2020
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 NumberLH-0033
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/19/2020
Initial Report FDA Received Date07/10/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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