CHLORAPREP ONE STEP 1.5 ML FREPP
Report
- Report Number
- 3004932373-2022-00058
- Event Type
- Injury
- Date Received
- February 28, 2022
- Date of Event
- December 15, 2021
- Report Date
- May 4, 2022
- Manufacturer
- CAREFUSION 213, LLC 0113
- Product Code
- OJU
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MT, US
- Reporter Occupation
- 501
Narratives
(B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
(B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
BATCH RECORD FOR PN 930299 LN 1246784 WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES RELATED TO THE DEFECT OF "GLASS ON FOAM OR PLASTIC BODY" OR "OPEN SEAL" DURING THE MANUFACTURING OF THE LOT. WITHOUT THE ACTUAL SAMPLE FOR ANALYSIS THE ROOT CAUSE COULD NOT BE CONFIRMED. 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. H3 OTHER TEXT : SEE NARRATIVE
MATERIAL# 930299. BATCH# 1246784. IT WAS REPORTED SHARPS: VERBATIM: :DESCRIBE THE EVENT OR PROBLEM: ADULT FEMALE BEING PREPARED FOR AN IV PLACEMENT BEFORE HER BILATERAL BREAST MRI EXAM. AS THE TECHNOLOGIST WAS CLEANING THE SKIN THE PATIENT WAS SCRAPED BY SOMETHING POSSIBLY INSIDE/ON THE CHLORHEXIDINE SKIN PREP - LEFT ANTECUBITAL/FOREARM AREA - THERE WAS SKIN EROSION SUBSTANTIAL ENOUGH TO CAUSE A BLEED. PATIENT WAS ASSESSED BY RADIOLOGY RN AND SKIN WAS CLEANED & ANTISEPTIC AROUND THE AFFECTED AREA AND DRESSING APPLIED. NO DELAY TO PROCEDURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PATIENT PREOPERATIVE SKIN PREPARATION: SITE-PREP FOR IV PLACEMENT.
MATERIAL# 930299. BATCH# 1246784. IT WAS REPORTED SHARPS: VERBATIM: DESCRIBE THE EVENT OR PROBLEM: ADULT FEMALE BEING PREPARED FOR AN IV PLACEMENT BEFORE HER BILATERAL BREAST MRI EXAM. AS THE TECHNOLOGIST WAS CLEANING THE SKIN THE PATIENT WAS SCRAPED BY SOMETHING POSSIBLY INSIDE/ON THE CHLORHEXIDINE SKIN PREP - LEFT ANTECUBITAL/FOREARM AREA - THERE WAS SKIN EROSION SUBSTANTIAL ENOUGH TO CAUSE A BLEED. PATIENT WAS ASSESSED BY RADIOLOGY RN AND SKIN WAS CLEANED & ANTISEPTIC AROUND THE AFFECTED AREA AND DRESSING APPLIED. NO DELAY TO PROCEDURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PATIENT PREOPERATIVE SKIN PREPARATION: SITE-PREP FOR IV PLACEMENT.
MATERIAL# 930299 BATCH# 1246784 IT WAS REPORTED SHARPS VERBATIM DESCRIBE THE EVENT OR PROBLEM: ADULT FEMALE BEING PREPARED FOR AN IV PLACEMENT BEFORE HER BILATERAL BREAST MRI EXAM. AS THE TECHNOLOGIST WAS CLEANING THE SKIN THE PATIENT WAS SCRAPED BY SOMETHING POSSIBLY INSIDE/ON THE CHLORHEXIDINE SKIN PREP - LEFT ANTECUBITAL/FOREARM AREA - THERE WAS SKIN EROSION SUBSTANTIAL ENOUGH TO CAUSE A BLEED. PATIENT WAS ASSESSED BY RADIOLOGY RN AND SKIN WAS CLEANED & ANTISEPTIC AROUND THE AFFECTED AREA AND DRESSING APPLIED. NO DELAY TO PROCEDURE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? : PATIENT PREOPERATIVE SKIN PREPARATION: SITE-PREP FOR IV PLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 943917 | CHLORAPREP ONE STEP 1.5 ML FREPP | 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL | OJU | CAREFUSION 213, LLC 0113 | 1246784 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Female | Other |