MAUDE Adverse Event Report: CAREFUSION, INC UNKNOWN CHLORAPREP; 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 01/29/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4) initial mdr.A follow up will be submitted if additional information becomes available.(b)(4).Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the path of the vein became red after the use of chloraprep and inserting a catheter.

Event Description

Material no.Unknown, batch no.Unknown.It was reported that the path of the vein became red after the use of chloraprep and inserting a catheter.Verbatim: the health manager was contacted by a colleague because in her department 2 nurses communicated to her problems with lymphangitis following the use of chloraprep®.After disinfecting the skin using chloraprep® and after inserting the catheter, they noticed that the ¿path¿ of the vein was red.And that the next day the patient presented with lymphangitis but without pain and because of this they were going to re-perfused the patient.Per vendor follow-up: several patients, between 2 and 3 but not identified.The nurse doesn¿t remember exactly 1ml applicator was used each time.Red vein path has appeared after just after catheter insertion local atb sometimes administered.No known concomitant medical history.Sometimes,catheter was removed and patient were re-catheterized, only if pain was associated and/or if lymphangitis or red vein path lasted more than 24h.No specific medicine was used to resolve the side effect.

Manufacturer Narrative

Patient information was received after the first submission.Nothing else has changed since initial submission.

• Brand Name: UNKNOWN CHLORAPREP
• 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
• MDR Report Key: 11311435
• MDR Text Key: 231305474
• Report Number: 3004932373-2021-00047
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

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
• Initial Date Manufacturer Received: 01/29/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/24/2021
• Supplement Dates FDA Received: 02/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR