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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

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BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/25/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of recx4241 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported the tubing would not allow a flush , it was not clamped, they made multiple attempts to try to flush through it. When they removed the tubing and connected their flush to the device the line flushed fine just not through the tubing. No patient harm reported. Powerglide placed in upper arm.
 
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Brand NameFULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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 Key8629944
MDR Text Key145765977
Report Number3006260740-2019-01441
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741140679
UDI-Public(01)00801741140679
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF320088PT
Device Lot NumberRECX4241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/29/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/01/2018
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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