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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Difficult to Flush (1251); Material Twisted/Bent (2981)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/15/2019
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of redn3201 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the accucath would not flush, "it also would not go back in straight shape of catheter, it stayed bend". On (b)(6) 2019: no patient harm was reported, but had to remove iv catheter.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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 Key8675915
MDR Text Key147306773
Report Number3006260740-2019-01571
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153298
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC0202250
Device Lot NumberREDN3201
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received06/13/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/01/2019
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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