MAUDE Adverse Event Report: BARD POWERGLIDE; MID LINE CATHETER

Model Number M120101

Device Problems Difficult to Remove (1528); Retraction Problem (1536); Physical Resistance (2578)

Patient Problems Pain (1994); Vasoconstriction (2126)

Event Date 10/02/2014

Event Type  Injury  

Event Description

Vat rn placing power midline catheter on l arm at bedside.Venipuncture with 1 stick.Flash observed.Guidewire advanced without resistance.Catheter advanced without resistance.Upon retraction of needle, felt resistance.Vat rn wondered if venospasm and paused.Waited brief time and attempted retraction second time.Unable to retract.Patient reporting pain.Caller ir for consult.Ir called surgery to remove.(b)(6), 2014: device removed by surgeon, minor surgical cutdown without incident or harm to patient.

• Brand Name: POWERGLIDE
• Type of Device: MID LINE CATHETER
• Manufacturer (Section D): BARD; covington 30014
• MDR Report Key: 4174228
• MDR Text Key: 5021370
• Report Number: MW5038568
• Device Sequence Number: 1
• Product Code: LJS
• 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: 10/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M120101
• Device Lot Number: REYF1878
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR