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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70 CM NITINOL GUI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70 CM NITINOL GUI; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Medical Device Problem Code Difficult to Insert (1316)
Health Effect - Clinical Code Thrombus (2101)
Date of Event 12/12/2019
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 clinician found the device sheath to be difficult and traumatic to insert.It is further reported that this resulted in a dvt.
 
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Brand Name
POWERPICC SOLO CATHETER 6F RADIOLOGY BASIC TRAY (TRIPLE-LUMEN)(70 CM NITINOL GUI
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9547437
Report Number3006260740-2019-04049
Device Sequence Number11356626
Product Code LJS
UDI-Device Identifier00801741028502
UDI-Public(01)00801741028502
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K072230
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 01/03/2020
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 Number3396355
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/13/2019
Initial Report FDA Received Date01/03/2020
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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