MAUDE Adverse Event Report: BARD ACCESS SYSTEMSI NC. POWERGLIDE PRO; MIDLINE CATHETER

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/04/2017

Event Type  Injury  

Event Description

A (b)(6) f, admitted on (b)(6) 2017 through the ed, with acute respiratory failure and copd.On (b)(6) 2017, the nurse was attempting to place a powerglide midline to the pt's upper arm.The catheter sheared and was retained in the pt's arm, an x-ray was performed revealing that the sheared catheter was in the soft tissue.On (b)(6) 2017, the pt was taken to the operating room and had a plastic piece of the tubing removed under local anesthesia from the mid portion of the left upper arm, 3.7cm in length by less than 0.1 cm in diameter.Pt was discharged home the same day.Date of use: (b)(6) 2017.Diagnosis or reason for use: iv access.

• Brand Name: POWERGLIDE PRO
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMSI NC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 6806766
• MDR Text Key: 83211898
• Report Number: MW5071683
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 39