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 Skin Irritation (2076)

Event Date 10/29/2020

Event Type  Injury  

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.It was reported that the patient experienced skin irritation from chloraprep dressing kits.Per medwatch: this [pt info omitted] patient began therapy with remodulin (treprostinil sodium, concentration 2.5 mg/ml) on (b)(6) 2020 for primary pulmonary arterial hypertension.The current dose was reported as 0.046 ug/kg, continuous via intravenous route.On an un reported date in 2020, the patient experienced the event of skin irritation from chloraprep dressing kits (dermatitis contact).Action taken with iv remodulin and chloraprep was not reported for the event of dermatitis contact.At the time of reporting, the outcome of dermatitis contact was unknown.The reporter did not provide causality for the event of dermatitis contact.Diagnosis for use (continued): primary pulmonary arterial hypertension (pulmonary arterial hypertension), drug use for unknown indication (product used for unknown indication).Concomitant medical products (continued): esbriet (pirfenidone).

Event Description

It was reported that the patient experienced skin irritation from chloraprep dressing kits.

Manufacturer Narrative

No additional information was provided by united therapeutics.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.

• 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: 10817311
• MDR Text Key: 217900811
• Report Number: 3004932373-2020-00124
• 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: 11/12/2020

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: 10/29/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/12/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Weight: 61