MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. POWERGLIDE ST; MIDLINE CATHETER

Lot Number REHV2589

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

Event Description

J-loop portion on midline catheter snapped and broke in two when this tubing got caught in the bedrail.Replaced midline j-loop with standard stock j-loop.

• Brand Name: POWERGLIDE ST
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 18704357
• MDR Text Key: 335461703
• Report Number: MW5151574
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REHV2589
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1