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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F118100
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Code Available (3191)
Event Date 01/10/2020
Event Type  malfunction  
Event Description
The tip of a rfo-transducer tip detached from a midline catheter during it insertion on the patient. Following the incident, the patient has had multiple imaging studies done to try to locate rfo-transducer tip. Uf contacted the manufacturer of the powerglide pro midline catheter. Manufacturer sent a postage paid envelope for the return of the defective device.
 
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Brand NamePERIPHERAL CATHETER INSERTION KIT
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 Key10118520
MDR Text Key193967435
Report Number10118520
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 Risk Manager
Type of Report Initial
Report Date 05/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF118100
Device Catalogue NumberF118100
Device Lot NumberREDV1232
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2020
Device Age0 YR
Event Location Hospital
Date Report to Manufacturer06/04/2020
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

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