MAUDE Adverse Event Report: CAREFUSION 213, LLC 0113 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 Rash (2033)

Event Date 12/20/2021

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

It was reported that two patients who developed a skin rash after being exposed to alcoholic chlorhexidine.Verbatim: email verbatim: ¿case reference number (b)(4) (bd id:) is a literature case, title as stated above, initially identified on (b)(6) 2021, and concerns a patient of an unknown demographics who was treated with chlorhexidine (brand name unknown).This was an international multicentre, prospective cohort study of adults and children undergoing upper limb surgery aimed to evaluate the safety and effectiveness of different topical antiseptics before upper limb surgery.Consecutive adults and children undergoing surgery (elective or emergency) distal to the shoulder joint were eligible.Any hospital offering upper limb surgery, in any location or setting, was eligible to participate.Collaborators were required to enroll consecutive patients (to mitigate selection biases) during the recruitment phase from 1st march 2020 to 31st december 2020.The main outcome of interest was surgical site infection (ssi) within 90 days.Other outcomes of interest included the occurrence of adverse events associated with antiseptic use, such as an ignition fire (with alcohol as the accelerant), a chemical burn beneath a tourniquet, or a hypersensitivity reaction.A total of 2454 patients were included.The overall risk of ssi was 3.5 per cent.Antiseptics were categorized into five groups: alcoholic or aqueous povidone iodine (brand name unknown) (pvi) or chlorhexidine (brand name unknown) (chx) and others.The intervention was use of chx or povidone¿iodine (pvi) antiseptics in either aqueous or alcoholic form.No serious adverse events were reported; specifically, there were no ignition fires or chemical burns beneath tourniquets.The patient was one of two patients who developed a skin rash after being exposed to alcoholic chlorhexidine.This case is linked to the case (b)(4) (same literature article).¿ no further information provided at time of entry.Missing information: 23-dec-2021, please note that (b)(4) has been duplicated three times and assigned pv id numbers are: (b)(4).On 23-dec-2021, as discussed previously, when additional cases are opened from a single report please indicate the reason additional cases are necessary.We also agreed that these case should not be called ¿duplicate¿ cases but rather ¿additional¿ cases in order to avoid confusion.On 24-dec-2021, please note that after further review it was decided that additional cases (b)(4) will be deleted.On 26-dec-2021, as previously agreed, we will make sure not to use the term ¿duplicated¿ cases for such notifications in the future.On 28-dec-2021, the associated miq number is (b)(4).On 30-dec-2021, please find final cioms for case (b)(4) (pr number is missing).Kindly note that this non serious literature case does not require submission due to missing patient identifiers.

Manufacturer Narrative

No additional information was provided by a literature study from ciphur uk.Primevigilance 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 that two patients who developed a skin rash after being exposed to alcoholic chlorhexidine.Verbatim: email verbatim: ¿case reference number (b)(4) (bd id: ) is a literature case, title as stated above, initially identified on (b)(6) 2021, and concerns a patient of an unknown demographics who was treated with chlorhexidine (brand name unknown).This was an international multicentre, prospective cohort study of adults and children undergoing upper limb surgery aimed to evaluate the safety and effectiveness of different topical antiseptics before upper limb surgery.Consecutive adults and children undergoing surgery (elective or emergency) distal to the shoulder joint were eligible.Any hospital offering upper limb surgery, in any location or setting, was eligible to participate.Collaborators were required to enrol consecutive patients (to mitigate selection biases) during the recruitment phase from (b)(6) 2020 to (b)(6) 2020.The main outcome of interest was surgical site infection (ssi) within 90 days.Other outcomes of interest included the occurrence of adverse events associated with antiseptic use, such as an ignition fire (with alcohol as the accelerant), a chemical burn beneath a tourniquet, or a hypersensitivity reaction.A total of (b)(4) patients were included.The overall risk of ssi was (b)(4).Antiseptics were categorized into five groups: alcoholic or aqueous povidone iodine (brand name unknown) (pvi) or chlorhexidine (brand name unknown) (chx) and others.The intervention was use of chx or povidone¿iodine (pvi) antiseptics in either aqueous or alcoholic form.No serious adverse events were reported; specifically, there were no ignition fires or chemical burns beneath tourniquets.The patient was one of two patients who developed a skin rash after being exposed to alcoholic chlorhexidine.This case is linked to the case (b)(4) (same literature article).¿ no further information provided at time of entry.Missing information.(b)(6) 2021 please note that (b)(4) has been duplicated three times and assigned pv id numbers are: (b)(4).(b)(6) 2021: as discussed previously, when additional cases are opened from a single report please indicate the reason additional cases are necessary.We also agreed that these case should not be called ¿duplicate¿ cases but rather ¿additional¿ cases in order to avoid confusion.(b)(6) -2021: please note that after further review it was decided that additional cases (b)(4) will be deleted.(b)(6) 2021: as previously agreed, we will make sure not to use the term ¿duplicated¿ cases for such notifications in the future.(b)(6) 2021: the associated miq number is (b)(4).(b)(6) 2021: please find attached final cioms for case (b)(4) (pr number is missing).Kindly note that this non serious literature case does not require submission due to missing patient identifiers.

• Brand Name: CHLORAPREP UNKNOWN
• Type of Device: 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL
• Manufacturer (Section D): CAREFUSION 213, LLC 0113; 1550 northwestern dr; el paso TX 79912
• 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: 13289732
• MDR Text Key: 289338126
• Report Number: 3004932373-2022-00007
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• 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
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other