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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EZ HUBER 22G X 1.5IN WITH NEEDLELESS Y-SITE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS EZ HUBER 22G X 1.5IN WITH NEEDLELESS Y-SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of reep3322 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported via medwatch: "patient accessed with bard portacath needle 22g 3/4-inch needle and when drawing blood air entered the line. All connections were tight but continued to draw air. Needle was removed and a new one was place and no problem. " what problem did the user have: "device malfunction - that is, the device did not do what it was intended to do. ".
 
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Brand NameEZ HUBER 22G X 1.5IN WITH NEEDLELESS Y-SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key10617527
MDR Text Key209960470
Report Number3006260740-2020-03423
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040533
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberSH22-75YS
Device Lot NumberREEP3322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received09/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2020
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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