MAUDE Adverse Event Report: CR BARD CR BARD GUIDEWIRE

Model Number 5FR 2-LUMEN POWER INJECTION PICC

Device Problems Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2016

Event Type  Other  

Event Description

(b)(6) year old patient was having a picc placed by vascular access team.Guidewire encountered resistance during insertion through needle.Guidewire could not be withdrawn through needle.Needle was removed at bedside and wire was taped in place.Complete guidewire was removed intact by intervention radiology without separation and no harm to the patient.The wire was discarded.A new picc was successfully placed in ir.

• Brand Name: CR BARD GUIDEWIRE
• Type of Device: GUIDEWIRE
• Manufacturer (Section D): CR BARD
• MDR Report Key: 5570177
• MDR Text Key: 42510632
• Report Number: MW5061617
• Device Sequence Number: 1
• Product Code: DQX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: 5FR 2-LUMEN POWER INJECTION PICC
• Device Catalogue Number: 250508
• Device Lot Number: REAP0801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 86 YR