WALKMED
Received Aug 18, 2017 · Event occurred Jul 25, 2017
Report 1723533-2017-00015 · MDR key 6805273
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Not reported
- No Consequences Or Impact To Patient
- Chemical Exposure
- No Consequences Or Impact To Patient
- Chemical Exposure
Narrative
Additional Manufacturer Narrative
TWO TUBE SET LEAKS AND A POTENTIAL BAG LEAK WERE NOTED BY (B)(6) (1723533-2017-0013, 1723533-2017-0014, AND 1723533-2017-0015).
Description of Event or Problem
(B)(6) SUBMITTED A COMPLAINT FOR A TUBESET WITH A BROKEN LUER LOCK. UPON RECEIPT OF THE RETURNED DEVICES, THE LUER LOCKS WERE FOUND TO BE CRACKED, LIKELY DUE TO CLEANING WITH ALCOHOL WHICH DEGRADES THE MATERIAL AND IS ADVISED AGAINST. THE BAG BEING USED AT THE TIME DID NOT HAVE ANY LEAKS. INCIDENT OCCURRED IN THE PHARMACY CLEANING ROOM. INCIDENT OCCURED DURING CLEANING, NOT DURING TREATMENT. CONFIRMED NO EXPOSURE TO DRUG, THERE WAS NO REPORT OF HARM OR INJURY.