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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. BARD PORT ACCESS SYSTEM

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BARD ACCESS SYSTEMS, INC. BARD PORT ACCESS SYSTEM Back to Search Results
Model Number AN142010G
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/21/2018
Event Type  Injury  
Event Description
Nursing was setting up a sterile field to access a pt port a cath. When nurse opened the 20 gauge, 1 inch needle. It was found to be bent. Nurse unable to use this needle and retrieved a new one to complete procedure. No pt harm.
 
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Brand NameBARD
Type of DevicePORT ACCESS SYSTEM
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
salt lake city UT 84116
MDR Report Key7553107
MDR Text Key109675205
Report NumberMW5077498
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2019
Device Model NumberAN142010G
Device Catalogue NumberAN142010G
Device Lot NumberRECQ2253
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/29/2018 Patient Sequence Number: 1
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