FDA Adverse Event Malfunction Summary report: N

CHLORAPREP ONE-STEP HILITE ORANGE

MDR report key: 12337485 · Received August 18, 2021

Report

Report Number: 3004932373-2021-00391
Event Type: Malfunction
Date Received: August 18, 2021
Date of Event: March 22, 2021
Report Date: September 27, 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

FAILURE MODE WAS NOT CONFIRMED FOR THIS COMPLAINT DUE TO NO PICTURES OR SAMPLES SENT FOR ANALYSIS. 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 TREND. PRODUCTION BATCH HISTORY RECORDS FOR APPLICATOR PN 930815 LOT NUMBER 0339543 WERE REVIEWED AND NO NON-CONFORMITIES, FAILURES, DEVIATIONS, OR REWORK ACTIVITIES OCCURRED DURING THE MANUFACTURING OF THIS LOT SIMILAR TO THE REPORTED ISSUE OR THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. RECORDS REVIEWED INDICATE THAT THE LOT PASSED ALL THE IN-PROCESS INSPECTIONS.

Description of Event or Problem · 0

MATERIAL NO.: 930815. BATCH NO.: 0339543. IT WAS REPORTED BY THE DISTRIBUTOR THAT THERE WAS FOREIGN PARTICLE. PER REPORT: FOREIGN PARTICLE.

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 PARTICLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1235259	CHLORAPREP ONE-STEP HILITE ORANGE	2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL	KXG	CAREFUSION, INC		0339543

Patients

Seq	Age	Sex	Outcome	Treatment
1