MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP SEPP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 270449

Device Problem Defective Component (2292)

Patient Problem Laceration(s) (1946)

Event Date 06/30/2020

Event Type  Injury  

Manufacturer Narrative

Pr 1798600 initial emdr submission.A follow up emdr will be submitted if additional information becomes available.Device problem code: 1946, patient problem code: 2292.

Event Description

It was reported that a glass shard went though the applicator and cut the user on the hand causing bleeding.

Event Description

It was reported that a glass shard went though the applicator and cut the user on the hand causing bleeding.

Manufacturer Narrative

No samples or photos available for analysis.A visual inspection of retained samples were performed.There were no visual signs of cracked tubes, broken ampoules and/or shards of glass.However, historical trend has shown that this failure mode may occur due to the design when multiple activation occurs.Instructions for use specify that to activate applicator it needs to be squeezed gently ¿only once¿.If the applicator was pinched several times this could be the probable cause for the failure mode.No further actions are required at this time.This failure mode will continue to be tracked and trended.H3 other text : see narrative below.

• Brand Name: CHLORAPREP SEPP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10546658
• MDR Text Key: 207330779
• Report Number: 3004932373-2020-00051
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 270449
• Device Lot Number: 9217468
• Date Manufacturer Received: 09/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR