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

Model Number F120080T

Device Problems Break (1069); Positioning Failure (1158); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2022

Event Type  malfunction  

Event Description

As the rrt vascular access specialist attempted to insert midline catheter she needed to remove catheter because she did not feel it was in the correct place, she felt resistance while trying to remove and stopped, attempted a second time to remove catheter and felt no resistance.Upon removal of the catheter she noticed it looked short and realized that the catheter was not intact.She used the ultrasound to scan the vessel and saw what she thought appeared to be the catheter in the brachial vein.A call was placed to vascular surgeon, while pressure was held above the site.The vascular surgeon instructed to cover the insertion site then apply a 3m¿ tegaderm¿ dressing on the insertion site.The patient did not appear to be in any distress during any of this.Patient had surgery the next day under local/iv sedation.In speaking with the vascular surgeon after the surgery, he was of the opinion that the catheter tip wasn't in the brachial vein but in the soft tissue.Device manufacturer would like the catheter so they can investigate.

• Brand Name: POWERGLIDE
• Type of Device: CATHETER,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 Key: 14753603
• MDR Text Key: 294408097
• Report Number: 14753603
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: F120080T
• Device Catalogue Number: F120080T
• Device Lot Number: REFZ1243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/31/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1