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

Catalog Number 930815

Device Problems Material Fragmentation (1261); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/18/2021

Event Type  malfunction  

Event Description

Prior to procedure, chloroprep skin prep was used.Before applying to patient skin, the end of the stick opened (cap came off) as i shook the stick and small glass shards and contents of the prep were dispersed all over myself and the floor.Skin prep applicator saved for quality.

• Brand Name: CHLORAPREP
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): BECTON-DICKINSON; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 11292573
• MDR Text Key: 230696462
• Report Number: 11292573
• 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: 01/20/2021

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 Catalogue Number: 930815
• 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: 01/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1