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 02/11/2021

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 additional information was provided by (b)(6) did reach out to obtain more information 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 application site hypersensitivity to chloraprep.Initial information was processed with additional information received on 05-jan-2021.This solicited report received from health care professional and patient via ppsphn002323: sp services accredo, concerned a [omitted], and height was not reported.The patient's concurrent conditions included primary pulmonary hypertension.The patient was treated with macitentan (tablet, oral, batch number: zm021b0101 expiry: 30-nov-2023) 10 mg, 1 time every 1 day, therapy dates were not reported for primary pulmonary hypertension non-company suspect drugs.Included: chlorhexidine gluconate/isopropanol (form of admin, route of admin, and batch number were not reported) dose, frequency, and therapy dates were not reported; and treprostmil sodium (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported, and dose, frequency, and therapy dates were not reported for an unspecified indication.No concomitant medications were reported on an unspecified date, the patient changed from remodulm subcutaneous to remodulin intravenous (iv) therapy the patient reported she was doing just as good at current of remodulin iv as she did with the subcutaneous dose.On an unspecified date, the patient had severe subcutaneous site pam which impacted her quality of life.The patient reported she also had occasional headache and nausea with remodulin iv but there was no leg pain like she did with the subcutaneous dose the patient reported sensitivity to chloroprep and requested iodine dressing change kits on an unspecified date, the surgeon placed patient's hickman m the wrong place so the patient will go back to the hospital on 08-jan-2021 to have it replaced.The action taken with macitentan, treprostinil sodium, and chlorhexidine gluconate/isopropanol was not reported.The outcome of the severe subcut site pam, occasional headache, nausea with iv, sensitivity to chloraprep, surgeon placed hickman in the wrong place and leg pain was not reported.The reporter provided no causality assessment.Company causality between macitentan, and surgeon placed hickman in the wrong place, severe subcut site pain, nausea with iv, sensitivity to chloraprep, and leg pam was not related, and between macitentan, and occasional headache was related.This report was non-senous.This case, involving the same patient is linked to (b)(4).

• 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
• Manufacturer (Section G): CAREFUSION, INC; 75 n. fairview drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 11365630
• MDR Text Key: 244055688
• Report Number: 3004932373-2021-00069
• Device Sequence Number: 1
• Product Code: KXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2021

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 112