CONTIPLEX
Received May 15, 2019
Report 2523676-2019-00062 · MDR key 8612047
Device
Generic name
Nerve Block Tray (kit)
Manufacturer
B. Braun Medical Inc.Catalog number
332103
Lot number
0061638374
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.
Description of Event or Problem
AS REPORTED BY THE USER FACILITY: THE CUSTOMER OPENED A TRAY AND DISCOVERED FLUID DROPLETS WITHIN THE SYRINGE. NO INJURY REPORTED.
Additional Manufacturer Narrative
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER 400430110. NO SAMPLE WAS RECEIVED FOR FURTHER EVALUATION. DUE TO PREVIOUS COMPLAINTS FOR THE SAME ISSUE, OUR INTERNAL DOCUMENT WAS UPDATED WITH PICTURES AND INSTRUCTIONS TO CLARIFY THE HANDLING OF THE PLUNGER TIPS. ADDITIONALLY, PICTURES OF UNACCEPTABLE SYRINGES WERE ALSO ADDED. THIS DOCUMENT BECAME EFFECTIVE ON 2019-04-26. SINCE THIS LOT WAS PRODUCED BEFORE THIS CHANGE, NO FURTHER ACTIONS WILL BE TAKEN AT THIS TIME. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.