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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/13/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of ascvs0292 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the package was found unsealed, the device is not in sterile condition was suspected. No other information was provided.
 
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Brand NameSAFESTEP HUBER NEEDLE SET 22G 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 Key9012328
MDR Text Key160163852
Report Number3006260740-2019-02659
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
Reporter Occupation
Type of Report Initial
Report Date 09/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberLH-0029
Device Lot NumberASCVS0292
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2018
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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