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

Catalog Number UNKNOWN

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

Patient Problem Abrasion (1689)

Event Date 11/16/2021

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

Material no.: unknown.Batch no.: unknown.Verbatim: we use chloraprep in our iv start kits, and one of the nurses recently used the device and found that there was glass in it, which resulted in a minor cut (to the nurse, not the patient).

Manufacturer Narrative

Lot number provided is not a valid bd lot number.Photograph was provided but failure mode could not be confirmed by photograph provided.No sample was received for analysis; therefore, the failure mode could not be confirmed, nor could the root cause be determined.No further action will be taken based on no valid lot number provided and no sample received for analysis.Bd will continue to track & trend.H3 other text: see narrative.

Event Description

Material no.: unknown.Batch no.: unknown.2021-300.01 verbatim: we use chloraprep in our iv start kits, and one of the nurses recently used the device and found that there was glass in it, which resulted in a minor cut (to the nurse, not the patient).Can you confirm that there is glass in these products? is there glass in the larger chlorapreps as well? have you heard of these issues before?.

• Brand Name: UNKNOWN CHLORAPREP
• 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: 12904493
• MDR Text Key: 287431963
• Report Number: 3004932373-2021-00509
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other