FDA Adverse Event Malfunction Summary report: N

CHLORAPREP ONE-STEP HI-LITE ORANGE

MDR report key: 12337887 · Received August 18, 2021

Report

Report Number: 3004932373-2021-00399
Event Type: Malfunction
Date Received: August 18, 2021
Date of Event: July 21, 2021
Report Date: October 12, 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

PHOTOS WERE PROVIDED AND BD WAS ABLE TO CONFIRM THE FAILURE MODE. THE BATCH RECORD FOR PN 930815 LN 1089896 WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO "MISSING PLEDGET" DURING THE MANUFACTURING OF THIS LOT. FURTHERMORE, THE MAINTENANCE LOGBOOK WAS REVIEWED AS WELL AND THERE WERE NO ISSUES REPORTED WITH THE FUNCTION OF THE PLEDGET PRESENCE SENSOR DURING THE MANUFACTURING OF THE LOT. IT IS MOST PROBABLE THAT THE SENSOR DID NOT FUNCTION CORRECTLY AND FAILED TO ALERT THE ABSENCE OF THE PLEDGET IN THE APPLICATOR.

Description of Event or Problem · 0

MATERIAL NO.: 930815 BATCH NO.: 1089896 IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT THERE WAS NO DYE IN THE APPLICATOR. PER COMPLAINT FORM: A STAFF MEMBER TURNED IN A CHLORAPREP BECAUSE WHEN THEY WENT TO USE IT THERE WAS NO ORANGE DYE, BUT JUST THE LIQUID CAME OUT.

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 SALES REPRESENTATIVE THAT THERE WAS NO DYE IN THE APPLICATOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1237241	CHLORAPREP ONE-STEP HI-LITE ORANGE	2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL	KXG	CAREFUSION, INC		1089896

Patients

Seq	Age	Sex	Outcome	Treatment
1