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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20GX 1" NEEDLELESS Y SITE SET, ADMINISTRATION, INTRAVASCULAR

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C.R. BARD, INC. (BASD) -3006260740 HUBER PLUS 20GX 1" NEEDLELESS Y SITE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/25/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of refq2454 showed three other similar product complaint(s) from this lot number.
 
Event Description
It was reported that leakage from y site needleless connection during flushing on 3 piccs. It was stated the devices weren't used on a patient. They found the leakage when they were performing the pre-flush prior to inserting the needle into the chemoport. Saline was used for flushing. This report addresses the second device.
 
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Brand NameHUBER PLUS 20GX 1" NEEDLELESS Y SITE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas 88780
MX 88780
Manufacturer Contact
kayla olsen
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12629138
MDR Text Key276390493
Report Number3006260740-2021-04364
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 Other,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number012001NY
Device Lot NumberREFQ2454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/13/2021 Patient Sequence Number: 1
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