MAUDE Adverse Event Report: CAREFUSION, INC CHLORAPREP UNKNOWN; 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 Reaction (2414)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).No samples, photos or product/lot information was provided for evaluation.No further actions are required at this time.Unfortunately, as a result, a potential root cause can not be defined and no corrective actions are required.If additional information becomes available, bd will re-open and re-investigate this record.This failure mode will continue to be tracked and trended.

Event Description

Date received for intake: (b)(6) 2020.Material no.: unknown, batch no.: unknown.It was reported that the patient experienced application site rash using chloraprep.Application site: rash, non-serious expected.

Manufacturer Narrative

No additional information was provided by the agence nationale de sécurité du médicament et des produits de santé.Propharma did reach out to obtain with no success.Should additional information be available in the future, the complaint will be re-opened and investigated.All complaints are reviewed during monthly quality/safety meetings.In addition, complaints are trended at monthly quality data analyst meetings and quarterly plant management review meetings.See narrative below.

Event Description

Date received for intake: (b)(6) 2020.Material no.: unknown; batch no.: unknown.It was reported that the patient experienced application site rash using chloraprep.Application site rash: non-serious expected.

• Brand Name: CHLORAPREP UNKNOWN
• 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: 10771224
• MDR Text Key: 214148495
• Report Number: 3004932373-2020-00121
• 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
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/20/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR