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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 19G X 1IN NEEDLELESS Y SITE SET, ADMINISTRATION, INTRAVASCULAR

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BARD ACCESS SYSTEMS HUBER PLUS 19G X 1IN NEEDLELESS Y SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problems Failure to Infuse (2340); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of reby0669 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that nurse opened this set of huber needle and started to prime the huber needle with 10 cc heparin saline. She felt resistance of infusing huber needle from the luer lock syringe and huber tube was not clamped. She infused slightly harder and found that only a few drops of heparin saline were out from huber needle. She stopped infusing and informed her nurse manager immediately. Nurse manger instructed the nurse to open a new box of huber needle for this patient.
 
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Brand NameHUBER PLUS 19G X 1IN 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 Key8804107
MDR Text Key151566478
Report Number3006260740-2019-02036
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K993848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/11/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number011901NY
Device Lot NumberREBY0669
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
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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