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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT BARD POLY MIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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BARD ACCESS SYSTEMS DOT BARD POLY MIDLINE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/04/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reeq0690 showed no other similar product complaint(s) from this lot number.
 
Event or Problem Description
It was reported the microintroducer folded (fish mouthed) when trying to insert it.It was stated the user had to trim the microintroducer and reinsert non-tapered.
 
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Brand Name
DOT BARD POLY MIDLINE
Common Device Name
CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key10457518
Report Number3006260740-2020-03046
Device Sequence Number19137006
Product Code LJS
UDI-Device Identifier00801741121609
UDI-Public(01)00801741121609
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K001901
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/26/2020
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 Expiration Date08/31/2021
Device Model NumberN/A
Device Catalogue NumberCK000495A
Device Lot NumberREEQ0690
Was Device Available for Evaluation? No
Event Location Hospital
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/04/2020
Initial Report FDA Received Date08/26/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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