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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; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Code Available (3191)
Date of Event 09/27/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event or Problem Description
It was reported that the accucath was placed in patients right ac on (b)(6) 2018.On (b)(6) 2018 when line was being flushed, the bedside rn noticed that the iv was no longer intact and notified physician, nurse manager.Patient underwent multiple exams until catheter was found in her right ac.Patient was taken to surgery later that afternoon to have the catheter surgical removed.
 
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Brand Name
ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key7985673
Report Number3006260740-2018-02959
Device Sequence Number16185179
Product Code FOZ
UDI-Device Identifier00801741110917
UDI-Public(01)00801741110917
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K153298
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 10/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue NumberAC0201250
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/28/2018
Initial Report FDA Received Date10/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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