MAUDE Adverse Event Report: CAREFUSION 2200, INC. CHLORAPREP ONE STEP 1 ML APPLICATOR; APPLICATOR, ABSORBENT TIPPED, NON-STERILE

Catalog Number 260480

Device Problem Malposition of Device (2616)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/17/2019

Event Type  malfunction  

Event Description

Nurse in the emergency department was utilizing chloraprep step one 1 ml to prep skin.They opened the package, activated per direction and when placed finger on "handle" a shard of glass was sticking thru and puncture nurse's finger quite traumatically.

• Brand Name: CHLORAPREP ONE STEP 1 ML APPLICATOR
• Type of Device: APPLICATOR, ABSORBENT TIPPED, NON-STERILE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 8968919
• MDR Text Key: 156733975
• Report Number: 8968919
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2019

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: 260480
• Device Lot Number: 8123793
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10950 DA