FDA Adverse Event Malfunction Summary report: N

CHLORAPREP ONE-STEP HI-LITE ORANGE

MDR report key: 12338166 · Received August 18, 2021

Report

Report Number: 3004932373-2021-00400
Event Type: Malfunction
Date Received: August 18, 2021
Date of Event: March 25, 2021
Report Date: September 24, 2021
Manufacturer: CAREFUSION, INC
Product Code: KXG
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE BATCH RECORD FOR PN 930815 LN 0327868 WAS REVIEWED AND THERE ARE NO DEFECTS REPORTED RELATED TO "FOREIGN MATERIAL" DURING ROUTINE IN-PROCESS INSPECTIONS DURING THE PACKAGING OF THE LOT. WITHOUT A PHYSICAL SAMPLE IT IS NOT POSSIBLE TO DETERMINE THE ORIGIN OF THE FOREIGN PARTICLE AND THEREFORE A ROOT CAUSE CANNOT BE ESTABLISHED. 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.

Description of Event or Problem · 0

MATERIAL NO.: 930815, BATCH NO.: 0327868. IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS FOREIGN PARTICULATE. PER REPORT: FOREIGN PARTICULATE.

Additional Manufacturer Narrative · 1

(B)(4) INITIAL MDR. A FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Description of Event or Problem · 1

IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS FOREIGN PARTICULATE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1235941	CHLORAPREP ONE-STEP HI-LITE ORANGE	2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL	KXG	CAREFUSION, INC		0327868

Patients

Seq	Age	Sex	Outcome	Treatment
1