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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP STAND, INFUSION

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BARD ACCESS SYSTEMS STATLOCK PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP STAND, INFUSION Back to Search Results
Model Number N/A
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of judy0643 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that removed a statlock from patient prior to dressing change procedure, had a very difficult time removing it.
 
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Brand NameSTATLOCK PICC PLUS FIXED POST, CRESCENT PAD, INCLUDES SKIN PREP
Type of DeviceSTAND, INFUSION
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 Key9990450
MDR Text Key188689448
Report Number3006260740-2020-01493
Device Sequence Number1
Product Code FOX
UDI-Device Identifier00801741083389
UDI-Public(01)00801741083389
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2022
Device Model NumberN/A
Device Catalogue NumberVPPDFP
Device Lot NumberJUDY0643
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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