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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25

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BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25 Back to Search Results
Model Number AC0201250
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/10/2017
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, at this time, for evaluation.A lot history review (lhr) of rebv0152 showed five other similar product complaints from this lot number.Device not returned yet.
 
Event Description
It was reported by the facility, that the healthcare professional was performing a training with the device.When the cap was removed the catheter pulled out and remained inside the cap.Device was not used on patient.This file addresses device four of five.
 
Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Upon receiving additional information about the event, it was determined that a reportable event had not occurred.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebv0152 showed five other similar product complaints from this lot number.Device not returned yet.
 
Event Description
It was reported by the facility, that the healthcare professional was performing a training with the device.When the cap was removed the catheter pulled out and remained inside the cap.Device was not used on patient.This file addresses device four of five.
 
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Brand Name
ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
Type of Device
INTRAVASCULAR 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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key7068385
MDR Text Key93721746
Report Number3006260740-2017-02140
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741110917
UDI-Public(01)00801741110917
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 user facility
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 02/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberAC0201250
Device Catalogue NumberAC0201250
Device Lot NumberREBV0152
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/29/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/08/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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