BD¿ DEHP FREE INFUSION SET
Received Aug 22, 2017 · Event occurred Jul 25, 2017
Report 2243072-2017-00090 · MDR key 6810329
Device
Product problems
- Device Contamination with Chemical or Other Material
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
RESULTS: A SAMPLE WAS RETURNED FOR EVALUATION. A HAIR WAS FOUND INSIDE THE IV TUBE. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: BASED ON THE INVESTIGATION RESULT OF THE COMPLAINT CASE THE HAIR INSIDE THE IV SET TUBE WAS A HUMAN HAIR. WE SUPPOSE THAT WHEN THE TWO PARTS(SLEEVE STOPPER AND Y-CONNECTOR) WERE ASSEMBLED TOGETHER, A HAIR MAY HAVE STUCK ONTO ONE OF THEM AND FLOWED INSIDE THE Y-CONNECTOR DUE TO STATIC ELECTRICITY. DEFECT DUE TO INSUFFICIENT CLEANNESS OF WORK STAND OR WORK FLOOR OR SMOCK. CAPA (B)(4) HAS BEEN OPENED. (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A HAIR WAS FOUND IN THE TUBING OF A BD¿ DEHP FREE INFUSION SET DURING USE. NO INJURY OR MEDICAL INTERVENTION.