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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK CV PLUS SLIDING POST STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 STATLOCK CV PLUS SLIDING POST STAND, INFUSION Back to Search Results
Model Number N/A
Device Problem Contamination of Device Ingredient or Reagent (2901)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/03/2020
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of jucrx133 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (jucrx133) have been reported from the same facility in (b)(6).
 
Event Description
It was reported, "when maintaining the patient's cvc, check the disposable items after routine disinfection, and find foreign objects before sticking, apologize to the patient, re-sterilize, and replace the sile buckle for re-fixing. ".
 
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Brand NameSTATLOCK CV PLUS SLIDING POST
Type of DeviceSTAND, INFUSION
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 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 north 5600 west
salt lake city 84116
8015950700
MDR Report Key10662959
MDR Text Key212453849
Report Number3006260740-2020-20038
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/12/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberCV0220CE
Device Lot NumberJUCRX133
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2018
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: 10/12/2020 Patient Sequence Number: 1
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