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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 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/16/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported that after use on the patient, the needle could not be retracted (to the metal sleeve) completely.
 
Manufacturer Narrative
The initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.During investigation, the safety mechanism functioned as intended.
 
Event Description
It was reported that after use on the patient, the needle could not be retracted (to the metal sleeve) completely.
 
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Brand Name
SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9112509
MDR Text Key159944243
Report Number3006260740-2019-02808
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00801741066207
UDI-Public(01)00801741066207
Combination Product (y/n)N
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/02/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberLH-0031
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2019
Event Location Hospital
Date Manufacturer Received09/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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