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

Catalog Number 930815

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

Patient Problem Laceration(s) (1946)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

(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 chloraprep ampoule shattered verbatim: ip chloraprep *not enough info provided* we were notified of a complaint from a customer stating that the chloraprep ampoule shattered.If it is indicated that a sample is available please provide shipping instructions within 30 days or the sample will be disposed of.External #: (b)(4).

Event Description

It was reported that chloraprep ampoule shattered.Verbatim: chloraprep *not enough info provided* we were notified of a complaint from a customer stating that the chloraprep ampoule shattered.If it is indicated that a sample is available please provide shipping instructions within 30 days or the sample will be disposed of.External #(b)(4) & (b)(4).

Manufacturer Narrative

No samples or photos were available for evaluation.As a result, bd was unable to verify the reported issue or determined a definitive root cause at this time.A production record review was completed for batch/lot 1177228 and no non-conformance was noted during the manufacturing of this lot.If a sample or photo becomes available, bd will re-open the record and investigate accordingly.No further action will be taken.This failure mode will continue to be tracked and trended.

• Brand Name: CHLORAPREP ONE STEP HI-LITE ORANGE
• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 13172263
• MDR Text Key: 291751024
• Report Number: 3004932373-2021-00547
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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: 1177228
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Other