MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP SWABSTICK; 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL

Catalog Number 260100

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Reaction (2414)

Event Date 01/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Material no.: 260100, batch no.: 0059490.It was reported 10 patients experienced rashes in the venipuncture area using chloraprep.Per email: my name is [omitted] and i am the director at inova blood donor services.We are a blood donation center in sterling, va that has long used chloraprep products.Recently, we adopted kitting through medline and we reported around 10 donors whom experienced rashes in the venipuncture area following phlebotomy.Attached is the documentation regarding the lot of swabs that we were provided to us by medline.Has this issue been reported to you already? have you seen issues with this lot?.

Manufacturer Narrative

No samples or photos are available for evaluation.Unfortunately, as a result, bd is unable to verify the reported issue or define a probable root cause.Production record review was completed for batch/lot 0059490 and there were no non-conformances recorded during the manufacturing of the lot.Furthermore, chemistry and microbiology results for solution pn 0-710282 (used in product 260100 batch 005940) were reviewed and they were all within specification.There were no findings in these reviews that would indicate any contribution to the defect reported.No further actions are required at this time.This failure mode will continue to be tracked and trended.

Event Description

It was reported 10 patients experienced rashes in the venipuncture area using chloraprep.Per email: my name is [omitted] and i am the director at (b)(6).We are a blood donation center in (b)(6) that has long used chloraprep products.Recently, we adopted kitting through medline and we reported around 10 donors whom experienced rashes in the venipuncture area following phlebotomy.Attached is the documentation regarding the lot of swabs that we were provided to us by medline.Has this issue been reported to you already? have you seen issues with this lot?.

• Brand Name: CHLORAPREP SWABSTICK
• 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: 11261789
• MDR Text Key: 230060026
• Report Number: 3004932373-2021-00017
• 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: other,user facility
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 260100
• Device Lot Number: 0059490
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/01/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 03/31/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other