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

Catalog Number CHLORAPREP UNKNOWN

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

Patient Problem Irritation (1941)

Event Date 09/22/2020

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

It was reported that the patient experienced a rash over incisions, lower and upper abdomen.

Manufacturer Narrative

One photo was provided for evaluation.The photo does show irritation to an applied site.Unfortunately without the product/lot information or physical sample, bd is unable to verify our product caused the reported failure mode.In addition, a root cause is unable to defined at this time.No additional information was provided by torrance memorial.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.

Event Description

It was reported that the patient experienced a rash over incisions, lower and upper abdomen.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 10643205
• MDR Text Key: 210384137
• Report Number: 3004932373-2020-00071
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: CHLORAPREP UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 09/25/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other