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 Abrasion (1689)

Event Date 02/02/2022

Event Type  Injury  

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).Pv response: tue 2/15/2022 3:04 am: kindly note that there will be no late submission, because initial report (doin: (b)(6) 2021) for which the additional case was opened yesterday ((b)(4)) was considered as non-serious without patient identifiers and as such does not require submission to any regulatory authority.Based on the answers on fu questions received for the case (b)(4) (lrd: (b)(6) 2022), case was upgraded to serious and as such requires submission (due date: (b)(6) 2022).For additionally opened case ((b)(4)) follow-up will be opened as well (lrd: (b)(6) 2022) based on the above mentioned answers for the case (b)(4), because the reporter stated that both patients experienced the exact same event, and the case will also be submitted on time (due date: (b)(6) 2022).

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).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: 13661261
• MDR Text Key: 290941709
• Report Number: 3004932373-2022-00063
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 930815
• Device Lot Number: 1177228
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other