SHUNT PAK, 11.5FR DOUBLE-VALVE
Received Jun 22, 2022 · Event occurred Jun 9, 2022
Report 1625685-2022-00066 · MDR key 14775278
Device
Product problems
- Contamination
- Contamination
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
Description of Event or Problem
THE CUSTOMER REPORTED THAT THERE IS SOMETHING LIKE A LARGE PIECE OF VINYL BETWEEN THE OUTER TRAY AND INNER TRAY. VERBATIM: THERE IS SOMETHING LIKE A LARGE PIECE OF VINYL BETWEEN THE OUTER TRAY AND INNER TRAY. INCOMING INSPECTION DISCOVERED THIS CONTAMINATION BEFORE BEING USED FOR PATIENTS.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THERE IS SOMETHING LIKE A LARGE PIECE OF VINYL BETWEEN THE OUTER TRAY AND INNER TRAY. VERBATIM: THERE IS SOMETHING LIKE A LARGE PIECE OF VINYL BETWEEN THE OUTER TRAY AND INNER TRAY. INCOMING INSPECTION DISCOVERED THIS CONTAMINATION BEFORE BEING USED FOR PATIENTS.
Additional Manufacturer Narrative
(B)(4). FOLLOW-UP EMDR FOR DEVICE EVALUATION: ONE PHOTO AND TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, PIECE OF PLASTIC WAS IN THE EMPTY PACK OBSERVED. THE PLASTIC DID NOT RESEMBLE ANY PRODUCT COMPONENTS 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 0001458149 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 A PROBABLE ROOT CAUSE WAS MANUFACTURING RELATED. AWARENESS TRAINING WAS CONDUCTED. 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. H3 OTHER TEXT: SEE MANUFACTURE NARRATION.