MAUDE Adverse Event Report: BECTON DICKINSON CHLORAPREP; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Model Number 260815

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2021

Event Type  malfunction  

Event Description

Prior to prepping patient with chloraprep and cracking the glass vial on the inside, the top of the stick popped off and the glass vial flew out of the stick and hit the floor at a safe distance from patient.Lot number for this chloraprep stick is 0328213.I placed stick in a bag for evidence of incident.There have been 2 other events where the cap easily has come off the of the applicator although no event reports submitted.

• Brand Name: CHLORAPREP
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11243154
• MDR Text Key: 229118157
• Report Number: 11243154
• Device Sequence Number: 1
• Product Code: KXF
• 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: 01/13/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 260815
• Device Catalogue Number: 260815
• Device Lot Number: 0328213
• 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: 01/13/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1