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 Premature Labor (2465)

Event Date 11/22/2021

Event Type  Injury  

Event Description

It was reported that the foetus was exposed to chloraprep one step chlorhexidine and chlorhexidine gluconate via transplacental route.Verbatim: other serious criteria: medically significant premature baby [premature baby] foetal exposure during pregnancy [foetal exposure during pregnancy] case description: case reference number (b)(4) is a spontaneous case initially received from a healthcare professional via (b)(6) health authority ((b)(4)) on (b)(6) 2021, and concerns a female patient (foetus/baby) of an unspecified age.The patient's medical history and concomitant medications were not provided.On an unknown date, the foetus was exposed to chloraprep one step (chlorhexidine gluconate, isopropyl alcohol), chlorhexidine (brand name unknown) and chlorhexidine gluconate (brand name unknown) via transplacental route.Dosing details, indication, batch number and expiration date were not provided.On an unknown date, the foetus was also exposed via transplacental route to co-suspects calcium d-pantothenate/d-alpha tocopheryl acetate/nicotinamide/pyridoxine hydrochloride/riboflavin/thiamine hydrochloride/vitamin b12 (cyanocobalamin)/vitamin c (ascorbic acid)/zinc, diclectin (doxylamine succinate, pyridoxine hydrochloride), insulin and sildenafil, all for an unknown indications; humulin regular (insulin human) and metformin, both for type 2 diabetes mellitus; nifedipine for hypertension and methyldopa via an unknown route for an unknown indication.Dosing details were not provided.On an unknown date, after being exposed to the products, the foetus was born prematurely.At the time of the report, the outcome for the events was reported as not resolved.At the time of the report, the action taken chloraprep one step (chlorhexidine gluconate, isopropyl alcohol), chlorhexidine (brand name unknown) and chlorhexidine gluconate (brand name unknown) was not reported.The reporter assessed the events of premature baby and foetal exposure during pregnancy as serious due to medical importance of the conditions and did not provide causality assessments between the administration of chloraprep one step (chlorhexidine gluconate, isopropyl alcohol), chlorhexidine (brand name unknown), chlorhexidine gluconate (brand name unknown) and the reported events.No further information was provided.Company comment: the pregnant women was treated with chloraprep one step, chlorhexidine and chlorhexidine gluconate and reportedly the foetus was exposed to products via transplacental route.The foetus was born prematurely after unknown period of time.Co-suspect products included multivitamin product, diclectin, insulin, sildenafil, humulin regular, metformin, methyldopa and nifedipine.Mother¿s underlying hypertension and diabetes mellitus strongly confounded premature birth as it is known that those are risk factors for preterm delivery.Additionally, use of sildenafil points out that insufficient placental vascularization was present.Systemic exposure to chlorhexidine gluconate is negligible when applied cutaneously.However, no information regarding route of administration, timeline and clinical course was provided.Therefore, meaningful analysis cannot be conducted and causality assessment cannot be made with certainty for premature baby.Foetal exposure during pregnancy is considered possibly related per company convention.The case is serious due to medical significance.

Manufacturer Narrative

(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 the (b)(6) health authority.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.

• 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: 12972384
• MDR Text Key: 286431340
• Report Number: 3004932373-2021-00533
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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
• Report Date: 12/09/2021

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: 11/22/2021
• Initial Date FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other