BD E-Z SCRUB¿
Received Jul 13, 2023 · Event occurred Jun 14, 2023
Report 1710034-2023-00785 · MDR key 17316264
Device
Generic name
Impregnated Preoperative Scrub Brushes (3% Chloroxylenol (pcmx)
Manufacturer
Carefusion, IncCatalog number
371163
Lot number
3004854
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
TWO SAMPLES WERE AVAILABLE FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLES SHOWS A LIGHT BROWN COLORED PARTICLE OF THE SAME SIZE IN EACH OF THE TWO SAMPLES SENT. IN ADDITION, ONE UNIT HAS A WHITE, PARTIALLY TRANSLUCENT PARTICLE THAT MEASURES THE SAME LENGTH AND WIDTH OF THE BRISTLES IN THE BRUSH. THIS VERIFIED THE REPORTED ISSUE. THE PROBABLE ROOT CAUSE OF THE SMALL LIGHT BROWN FOREIGN MATTER IS LIKELY FOAM SPONGE DUST THAT ACCUMULATES DURING PRODUCTION. THE SECOND PARTICLE IS LIKELY A BRISTLE FROM THE BRUSH THAT WAS SEALED INTO THE PACKAGE. BOTH OF THESE PARTICLES ARE MATERIALS USED IN PRODUCTION; THEREFORE, THE RISK TO PRODUCT IS LOW. BATCH RECORD WAS REVIEWED, INCLUDING ALL ATTRIBUTE DATA, AND NO DEVIATIONS OR DISCREPANCIES WERE NOTED THAT WOULD CONTRIBUTE OR CAUSE THIS ISSUE. REVIEW OF RISK MANAGEMENT DOCUMENT SHOWS THAT SEVERITY RATING IS MODERATE FOR THIS DEFECT. VISUAL INSPECT OF RETAINED UNITS. IDENTIFIED ALL UNITS WERE PRESENT AND NO DEFECTS WERE OBSERVED. THE RETAINED UNITS ARE ACCEPTABLE. CORRECTIVE ACTIONS INCLUDE EQUIPMENT COVERS TO MITIGATE THE SPREAD OF DUST ARE IN THE PROCESS OF BEING INSTALLED. COMPLAINTS WILL CONTINUE TO BE TRENDED AND EVALUATED FOR FURTHER ACTION, IF NEEDED.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE DEBRIS FOUND IN PACKAGE SEALING SURFACE. VERBATIM: DEBRIS FOUND IN PACKAGE SEALING SURFACE. ADDITIONAL INFORMATION RECEIVED ON 16-JUNE-2023. 1. ARE YOU ABLE TO PROVIDE THE DATE OF INCIDENT? 6/14/2023. 2. WAS THIS NOTED UPON RECEIPT? WAS THE PRODUCT RECEIVED IN THIS CONDITION? NO, YES. 3. PLEASE CONFIRM IF THERE WAS PATIENT INVOLVEMENT. IF SO, WERE THERE ANY ADVERSE EVENT OR SERIOUS INJURY? NO, NO. 4. WAS THE DEBRIS EMBEDDED ON THE PACKAGING OR CAN BE REMOVED? YES, YES.
Additional Manufacturer Narrative
12JUL2023: PR 8203 344 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. IMDRF ANNEX E CODE HEALTH EFFECT ¿ CLINICAL CODE: E2403. IMDRF ANNEX A CODE MEDICAL DEVICE PROBLEM CODE: A18.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT THERE WERE DEBRIS FOUND IN PACKAGE SEALING SURFACE. VERBATIM: DEBRIS FOUND IN PACKAGE SEALING SURFACE.