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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 Problems Material Twisted/Bent (2981); Activation Problem (4042)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/16/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation. Results are expected soon. A lot history review (lhr) of asdqs190 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the needle could not be retracted during removal. No other information was provided.
 
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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
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key9596533
MDR Text Key190995473
Report Number3006260740-2020-00127
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 02/12/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
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 NumberASDQS190 (INVALID)
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received02/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2019
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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