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

Model Number F118101

Device Problems Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)

Patient Problem Insufficient Information (4580)

Event Date 09/01/2020

Event Type  malfunction  

Event Description

Nurse inserting a mid line into patient.Once skin was puncture with needle nurse was trying to engage the guidewire; but the device failed, and the guidewire did not engage.Nurse thought the guidewire deployed into the patient.X-rays were completed; negative for guidewire.Guidewire visible in the device.

• Brand Name: PERIPHERAL CATHETER INSERTION KIT
• 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: 10566339
• MDR Text Key: 207938289
• Report Number: 10566339
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F118101
• Device Catalogue Number: F118101
• Device Lot Number: REES0255
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Weight: 100