MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM); FOZ

Catalog Number M120101

Device Problem Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2014

Event Type  Injury  

Event Description

While they were pushing the wire, they allegedly felt resistance.Half the catheter was allegedly in the patient when the resistance was reported to be felt.When they went to pull out the wire, they realized that part of it was alleged to be still in the patient.It was reported that 6" of catheter was left in the patient.

Manufacturer Narrative

A lot history review (lhr) of reyj0298 showed no other similar product complaint(s) from these lot numbers.The manufacturer has received the sample and will be evaluated.Results are expected soon.

• Brand Name: POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM)
• Type of Device: FOZ
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake city UT
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4383621
• MDR Text Key: 15321370
• Report Number: 3006260740-2014-00634
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121073
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: M120101
• Device Lot Number: REYJ0298
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/31/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention