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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

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BARD ACCESS SYSTEMS ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25 Back to Search Results
Model Number N/A
Device Problem Kinked (1339)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device has not been returned to the manufacturer for evaluation, as the device remains in the patient. A lot history review (lhr) of rebt1448 showed no other similar product complaint(s) from this lot number.
 
Event Description
During training bard clinical specialist reported, the accucath catheter kinked when the rn retracted the guidewire before activating the safety. It was stated this was identified on ultrasound and the rn was able to retract the catheter to straighten out and float back in successfully.
 
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Brand NameACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
Type of DeviceINTRAVASCULAR CATHETER
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 Key6899530
MDR Text Key87750999
Report Number3006260740-2017-01712
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
Type of Report Initial
Report Date 09/27/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Model NumberN/A
Device Catalogue NumberAC0202250
Device Lot NumberREBT1448
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2017
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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