B.BRAUN
Received Dec 10, 2018
Report 2523676-2018-00102 · MDR key 8148468
Device
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). AS REPORTED BY THE USER FACILITY, IT WAS CONFIRMED THAT THE BATCH NUMBER WAS UNKNOWN AND THE SAMPLE WAS NOT AVAILABLE FOR FURTHER EVALUATION. WITHOUT THE ACTUAL DEVICE AND/OR LOT NUMBER, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: EVENT 3: COMPLAINT: CUSTOMER STATED THE SYRINGES IN THE PERIPHERAL NERVE BLOCK SUPPORT TRAY HAD "CONDENSATION" IN THEM. THEY APPEARED "CLOUDY". NO INJURY REPORTED.