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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST; DRESSING, WOUND, DRUG
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BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST; DRESSING, WOUND, DRUG Back to Search Results
Model Number N/A
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 04/08/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.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 during a health fair one of the unit champions had shared that the statlock wing had broken off on 3 pic0222's that were used in their custom dressing change kit.This report addresses the second of three statlocks.
 
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Brand Name
STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST
Common Device Name
DRESSING, WOUND, DRUG
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8741326
Report Number3006260740-2019-01791
Device Sequence Number13880240
Product Code LJS
UDI-Device Identifier00801741082962
UDI-Public(01)00801741082962
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/27/2019
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 NumberPIC0222
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/03/2019
Initial Report FDA Received Date06/27/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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