MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MICROINTRODUCER KIT; INDUCER, CATHETER

Model Number 0928950

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2016

Event Type  malfunction  

Event Description

The concern of the referral source is that there may have been a complication when the picc line was initially inserted.Possible defect.

• Brand Name: MICROINTRODUCER KIT
• Type of Device: INDUCER, CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; salt lake UT 84116
• MDR Report Key: 6360797
• MDR Text Key: 68524983
• Report Number: MW5068139
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2017
• Device Model Number: 0928950
• Device Lot Number: REAU2157
• 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
• Treatment: 5F MICRO EZTM MICROINTRODUCER KIT 7CM ML LENGTH; WIRE N NITRILE & NEEDLE LONG BEVEL