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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 Name
EZ HUBER 22G X 1.5IN WITH NEEDLELESS Y-SITE
Type of Device
SET, 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
UDI-Device Identifier00801741089060
UDI-Public(01)00801741089060
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
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2023
Device Model NumberN/A
Device Catalogue NumberSH22-75YS
Device Lot NumberREEP3322
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received 09/09/2020
Initial Date FDA Received10/01/2020
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
Patient Sequence Number1
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