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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. MIDLINE CATHETER KIT
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BARD ACCESS SYSTEMS, INC. MIDLINE CATHETER KIT Back to Search Results
Model Number S4153108BP
Device Problems Break (1069); Entrapment of Device (1212); Material Frayed (1262); Difficult to Remove (1528)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 01/04/2022
Event Type  malfunction  
Event Description
When the picc line was being removed the guide wire became stuck, and when it was removed the wire was frayed and the jtip had been lost.This fraying occurred distally along the guidewire very high up the humerus and the care provider did not feel that excessive force was used in advancing or retracting the guidewire.Radiology confirmed the retained guidewire fragment and determined that due to its small size, it was not clinically significant and risks inherent to attempted removal would outweigh any benefit.
 
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Brand Name
MIDLINE CATHETER KIT
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS, INC.
605 north 5600 west
salt lake city UT 84116
MDR Report Key13598844
MDR Text Key286117943
Report Number13598844
Device Sequence Number1
Product Code PND
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 01/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/25/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberS4153108BP
Device Catalogue NumberS4153108BP
Device Lot NumberREFW1458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/19/2022
Event Location Hospital
Date Report to Manufacturer02/25/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23725 DA
Patient SexMale
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