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

Catalog Number 260715

Device Problem Leak/Splash (1354)

Patient Problems No Known Impact Or Consequence To Patient (2692); Not Applicable (3189)

Event Date 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Material no.: 260715 batch no.: 9243915 it was reported that the chloraprep was leaking inside the sterile pouch.Per email: (b)(4).(b)(6) 2020 ep-dh leak chloraprep was leaking inside sterile pouch.1 yes 260715zp~psprms 260715 disc use 930715p (070720)applicator,prep,chloraprep,2% 9243915 no.

Manufacturer Narrative

No samples or photos were available for evaluation.Unfortunately, as a result, bd was unable to verify the reported issue and a root cause could not be defined.Production record review has been completed for batch/lot 9243915 and no non-conformances were noted during the manufacturing of this lot.No further actions are required at this time.This failure mode will continue to be tracked and trended.See narrative below.

Event Description

Material no.: 260715 batch no.: 9243915.It was reported that the chloraprep was leaking inside the sterile pouch.Per email: case (b)(4) (b)(6) 2020 (b)(6) 2020 ep-dh leak chloraprep was leaking inside sterile pouch.1 yes 260715zp~psprms 260715, disc use 930715p (070720)applicator,prep,chloraprep,2% 9243915 no.

• 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, INC; 75 n. fairview drive; vernon hills IL 60061
• MDR Report Key: 10934885
• MDR Text Key: 258241895
• Report Number: 3004932373-2020-00141
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 260715
• Device Lot Number: 9243915
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 01/29/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other