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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 SAFESTEP HUBER NEEDLE SET 22G X 0.75IN WITH Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number LH-0029YN
Device Problem Fail-Safe Did Not Operate (4046)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been received by the manufacturer for evaluation. A lot history review (lhr) review is not possible; as no manufacturing lot number has been provided.
 
Event Description
It was reported that the safety feature had difficulty to work when the needle was removed. There was no reported patient injury.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 22G X 0.75IN WITH Y-SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer Contact
shelly gilbert
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key10796243
MDR Text Key216687125
Report Number3006260740-2020-20399
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040527
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberLH-0029YN
Device Catalogue NumberLH-0029YN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/28/2020
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/05/2020 Patient Sequence Number: 1
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