MAUDE Adverse Event Report: C. R. BARD, INC. STAT LOCK STABILIZATION DEVICE; TAPE AND BANDAGE, ADHESIVE

Model Number PART OF MEDICHOICE IV START KIT

Device Problem Protective Measures Problem (3015)

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

Event Date 09/01/2018

Event Type  malfunction  

Event Description

When removed from the iv start kit package, the stat lock was in two pieces.The adhesive from the actual lock was not intact to the tape.

• Brand Name: STAT LOCK STABILIZATION DEVICE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): C. R. BARD, INC. ; salt lake city UT 84116
• MDR Report Key: 7859640
• MDR Text Key: 119791388
• Report Number: MW5079661
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• 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: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: PART OF MEDICHOICE IV START KIT
• Device Lot Number: MEDICHOICE IV KIT#01195649
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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