MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE; CATHETER, INTRAVASCULAR, THERAPEUTIC

Catalog Number M120081

Device Problems Break (1069); Kinked (1339); Retraction Problem (1536); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/07/2014

Event Type  malfunction  

Event Description

Nurse inserted midline catheter.Upon retraction of the wire she was unable to retract the wire from the catheter.The catheter broke off from the hub.Hemostats were utilized and the catheter was removed from the patient.Multiple kinks were noted in the catheter.

• Brand Name: POWERGLIDE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 n 5600 w; salt lake city UT 84116
• MDR Report Key: 3700179
• MDR Text Key: 15270133
• Report Number: 3700179
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: M120081
• Device Lot Number: REYA1484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2014
• Event Location: Hospital
• Date Report to Manufacturer: 03/26/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2014
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 74