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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS, INC. POWERGLIDE PRO CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F118100T
Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)
Patient Problem Insufficient Information (4580)
Event Date 05/11/2021
Event Type  malfunction  
Event Description
Nurse was placing a midline on a patient. As i inserted the wire, i met resistance. When i pulled the wire back, the outside coating broke in half. The only thing connecting the two wires was the stretchy, smaller wire that comes inside it. The wire was removed successfully but with much difficulty as it tip snagged on the patient's skin. The wire tip appears to be intact. Lot # reez2293, pflex rt 18g 10cm basic, f118100t.
 
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Brand NamePOWERGLIDE PRO
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key11929514
MDR Text Key254037074
Report Number11929514
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF118100T
Device Catalogue NumberF118100T
Device Lot NumberREEZ2293
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2021
Event Location Hospital
Date Report to Manufacturer06/03/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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