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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO MIDLINE CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO MIDLINE CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 00801741142666
Device Problems Break (1069); Positioning Problem (3009); Suction Failure (4039)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/10/2020
Event Type  Injury  
Event Description
Midline catheter was being placed via ultrasound and when rn unable to get a blood return or positive placement verification with wire advancement, the catheter was removed. Upon inspection of the catheter, the 2cm tip of the poly catheter was missing. Repeat elbow xray taken on (b)(6) 2020 and foreign body noted in the same place. Fda safety report id# (b)(4).
 
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Brand NamePOWERGLIDE PRO MIDLINE CATHETER
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
salt lake city UT 84116
MDR Report Key10534945
MDR Text Key207160919
Report NumberMW5096608
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number00801741142666
Device Catalogue NumberF120080T
Device Lot NumberREEP4157
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: 09/14/2020 Patient Sequence Number: 1
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