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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F BASIC TRAY WIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F BASIC TRAY WIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 01/31/2019
Type of Reportable Event Malfunction
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 power picc continues to block off repeatedly.This is apparently a recurring event.The number of occurrences was not provided.
 
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Brand Name
POWERPICC SOLO2 CATHETER WITH TIP LOCATION SYSTEM (TLS) STYLET 4F BASIC TRAY WIT
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 Key8404556
Report Number3006260740-2019-00513
Device Sequence Number11276263
Product Code LJS
UDI-Device Identifier00801741028618
UDI-Public(01)00801741028618
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K072230
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source user facility
Initial Reporter Occupation Nurse
Type of Report Initial
Report Date (Section B) 03/08/2019
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
Operator of Device Health Professional
Device Model NumberN/A
Device Catalogue Number9194118
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/19/2019
Initial Report FDA Received Date03/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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