MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 CHLORAPREP ONE STEP SEPP; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 270449

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

It was reported that the sepp broke the outer casing.Per complaint details received: thank you for sending me the lot number of the sepp that's glass broke the outer casing.Could you please isolate the box and if possible give me a little more info? when did the incident occur? was anyone injured? do you have any pictures of the product that was defective? i will log this as a product complaint this morning and someone will follow up with you shortly from our pharmaco vigilance team.

Manufacturer Narrative

Samples were available for evaluation.The samples received showed glass protruding barrel verifying the reported issue.Possible root causes include multiple activation and/or continued manipulation or incorrect actions method which could weaken the applicator wall increasing potential for glass protrusion.The production record review was completed for batch/lot 0245075 and no non-conformities, failures, deviations, or rework activities occurred during the manufacturing of this lot similar to the reported issue or that could have contributed to the reported failure mode.Records reviewed indicate that the lot passed all the in-process inspections.No further actions are required at this time.This failure will continue to be tracked and trended.H3 other text : see narrative below.

Event Description

It was reported that the sepp broke the outer casing.Per complaint details received: thank you for sending me the lot number of the sepp that's glass broke the outer casing.Could you please isolate the box and if possible give me a little more info? - when did the incident occur? - was anyone injured? - do you have any pictures of the product that was defective? i will log this as a product complaint this morning and someone will follow up with you shortly from our pharmaco vigilance team.

• Brand Name: CHLORAPREP ONE STEP SEPP
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• MDR Report Key: 12239202
• MDR Text Key: 263867095
• Report Number: 3004932373-2021-00344
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/20/2021

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 Expiration Date: 09/30/2023
• Device Catalogue Number: 270449
• Device Lot Number: 0245075
• Initial Date Manufacturer Received: 07/16/2021
• Initial Date FDA Received: 07/28/2021
• Supplement Dates Manufacturer Received: 09/20/2021
• Supplement Dates FDA Received: 09/20/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other