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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT DRESSING CHANGE KIT; DRESSING, WOUND, DRUG
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BARD ACCESS SYSTEMS DOT DRESSING CHANGE KIT; DRESSING, WOUND, DRUG Back to Search Results
Model Number N/A
Device Problem Misconnection (1399)
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 19kbk641 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported statlock kept opening up when they try to use the clamp.No other information was provided.
 
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Brand Name
DOT DRESSING CHANGE KIT
Type of Device
DRESSING, WOUND, DRUG
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
MEDLINE INDUSTRIES
11 norfolk st
mansfield MA 02048
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key10192892
MDR Text Key196384238
Report Number3006260740-2020-02223
Device Sequence Number1
Product Code FOX
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 user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberDC5090LF
Device Lot Number19KBK641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received06/04/2020
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 Sequence Number1
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