BD E-Z SCRUB
Received Mar 16, 2021 · Event occurred Feb 4, 2021
Report 1710034-2021-00196 · MDR key 11499277
Device
Generic name
Impregnated Preoperative Scrub Brushes (3% Chloroxylenol (pcmx))
Manufacturer
Bd SandyCatalog number
371163
Lot number
0133746
Product problems
- Contamination /Decontamination Problem
- Adverse Event Without Identified Device or Use Problem
- Contamination /Decontamination Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Hypersensitivity/Allergic reaction
- No Clinical Signs, Symptoms or Conditions
- Hypersensitivity/Allergic reaction
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
REVIEW OF THE MANUFACTURING BATCH RECORD AND LABORATORY RESULTS DID NOT DETERMINE ROOT CAUSE FOR THIS ISSUE. REVIEW OF PREVIOUS COMPLAINTS DID NOT IDENTIFY PREVIOUS COMPLAINTS FOR THIS LOT. REVIEW OF THE FINISHED GOOD BATCH RECORD, PART NUMBER 371163, LOT 0133746, WAS PERFORMED FOR ANY DISCREPANCIES OR DEVIATIONS, INCLUDING EXCESSIVE SOAP WEIGHT, THAT WOULD CONTRIBUTE TO THIS ISSUE. NO DEVIATIONS OR DISCREPANCIES WERE IDENTIFIED DURING THE REVIEW OF THE BATCH RECORD. REVIEW OF VENDOR¿S COA AND BD SANDY COA DID NOT IDENTIFY ANY OUT OF SPECIFICATIONS OR DISCREPANCIES THAT WOULD CONTRIBUTE TO THIS ISSUE. BD WILL CONTINUE TO TRACK AND TREND FOR THIS FAILURE MODE. H3 OTHER TEXT : SEE NARRATIVE SECTION.
Description of Event or Problem
THE CENTRUM DISTRIBUTOR REPORTS THAT SURGEON LSMF FROM THE COLON AND RECTUM AREA OF THE CENTRAL MILITARY HOSPITAL REPORTED THAT SHE HAS PRESENTED ERYTHEMA ON HER HANDS AFTER USING THE SURGICAL BRUSH CATALOG 371163 (PCMX 3%) FOR WHICH SHE REQUESTS THE CHANGE OF CATALOG TO 371073 (CHG 4%). IN ADDITION, SHE STATES THAT THE EPIDEMIOLOGY AREA OF THE HOSPITAL CARRIED OUT A STUDY WHERE THE PRESENCE OF MICROBIOTA WAS EVEN DETECTED IN THE AREA ALREADY WASHED WITH THE BRUSH. THIS CLAIM WAS OPENED TO INVESTIGATE: EYTHEMA. COMPLAINT PR (B)(4) WAS OPENED TO INVESTIGATE THE PRESENCE OF MICROBIOTA.
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
THE CENTRUM DISTRIBUTOR REPORTS THAT SURGEON LSMF FROM THE COLON AND RECTUM AREA OF THE CENTRAL MILITARY HOSPITAL REPORTED THAT SHE HAS PRESENTED ERYTHEMA ON HER HANDS AFTER USING THE SURGICAL BRUSH CATALOG 371163 (PCMX 3%) FOR WHICH SHE REQUESTS THE CHANGE OF CATALOG TO 371073 (CHG 4%). IN ADDITION, SHE STATES THAT THE EPIDEMIOLOGY AREA OF THE HOSPITAL CARRIED OUT A STUDY WHERE THE PRESENCE OF MICROBIOTA WAS EVEN DETECTED IN THE AREA ALREADY WASHED WITH THE BRUSH. THIS CLAIM WAS OPENED TO INVESTIGATE : EYTHEMA. COMPLAINT PR (B)(4) WAS OPENED TO INVESTIGATE THE PRESENCE OF MICROBIOTA.