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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 DEVICE, INTRAVASCULAR CATHETER SECUREMENT

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BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST DEVICE, INTRAVASCULAR CATHETER SECUREMENT Back to Search Results
Model Number N/A
Device Problem Insufficient Information (3190)
Patient Problem Complaint, Ill-Defined (2331)
Event Type  Injury  
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 Description
It was reported the patient reacted vigorously to the pad/adhesive part of a statlock device. No other information was provided.
 
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Brand NameSTATLOCK PICC PLUS CRESCENT TRICOT FIX-POST
Type of DeviceDEVICE, INTRAVASCULAR CATHETER SECUREMENT
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
DAVOL SURGICAL INNOVATIONS -9616067
ave. roberto fierro #6408
parque industrial aeropuerto
cd. juarez, chih s.a. de c.v. 32690
MX 32690
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key8421215
MDR Text Key138811806
Report Number3006260740-2019-00575
Device Sequence Number1
Product Code FOX
UDI-Device Identifier00801741082962
UDI-Public(01)00801741082962
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberPIC0222
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/14/2019 Patient Sequence Number: 1
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