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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, ACE 18GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS ACCUCATH, ACE 18GX2.25 CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Material Deformation (2976); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/02/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of redq2618 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (redq2618) have been reported from the same facility.
 
Event Description
The rn reported, "i had good blood return and good visual of the needle at the center of the vein. I advanced the guidewire and met resistance halfway and retracted. The guidewire was then stuck. I entered the vein a little higher and threaded the catheter in for a successful iv without use of the guidewire. The safety device would not work. We removed the needle and the guidewire was not visible. I assume it was looped inside the needle. ".
 
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Brand NameACCUCATH, ACE 18GX2.25
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 Key9627178
MDR Text Key193693198
Report Number3006260740-2020-00288
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162894
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 02/11/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberAC1182250
Device Lot NumberREDQ2618
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received01/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2019
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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