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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 Retraction Problem (1536)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/11/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of asdns0140 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the needle would not "retract completely at first time. Needle pull back forcefully again".
 
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Brand NameSAFESTEP HUBER NEEDLE SET 20G X 0.75IN
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key8755931
MDR Text Key149933716
Report Number3006260740-2019-01854
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K153440
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0031
Device Lot NumberASDNS0140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/09/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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