ECONOMY SOFT TISSUE BIOPSY TRAY
Received Nov 9, 2023 · Event occurred Oct 26, 2023
Report 1625685-2023-00107 · MDR key 18103621
Device
Product problems
- Contamination
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY CUSTOMER THAT HAIR FOUND INSIDE OF PACKAGING. VERBATIM. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. HAIR FOUND INSIDE OF PACKAGING. INJURIES OR ADVERSE EVENT: NO. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. PER FOLLOW-UP- LOOKS LIKE THE PACKAGE IS NOT OPEN.
Additional Manufacturer Narrative
(B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTO, HAIR WAS OBSERVED POTENTIALLY BE ADHERED TO THE SWABSTICK; THEREFORE, THE REPORTED FAILURE MODE WAS CONFIRMED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001525049 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT AND AWARENESS TRAINING WAS PROVIDED. A QUALITY NOTIFICATION WILL BE SENT TO THE SUPPLIER FOR AWARENESS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.
Description of Event or Problem
MATERIAL#: 4380 BATCH#: 0001525049. IT WAS REPORTED BY CUSTOMER THAT HAIR FOUND INSIDE OF PACKAGING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. HAIR FOUND INSIDE OF PACKAGING. INJURIES OR ADVERSE EVENT: NO. PER FOLLOW-UP- LOOKS LIKE THE PACKAGE IS NOT OPEN. SEE ATTACHED PICTURE.
Additional Manufacturer Narrative
(B)(4). INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A1801. PATIENT PROBLEM CODE: F27.