BD ORAL SYRINGE

Additional Manufacturer Narrative

H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT BD SYRINGE ORAL 5ML CLEAR CONTAINED FOREIGN MATTER/ VISIBLE SILICONE. VERBATIM: THERE ARE DOSAGE SYRINGES IN THE LOT WITH TWO DIFFERENT ISSUES: 1. CLEAR DROPS OF SOME KIND OF FLUID (SEE PICTURES SENT) INSIDE THE BARREL OF THE SYRINGE. IT COULD BE SILICONE, BUT WE NEED YOU TO CONFIRM THIS. IF YOU HAVE AN IR SPECTRA OF THE SILICONE USED ACCORDING TO THE SPECIFICATION, PLEASE SENT THIS TO US. OTHERWISE, WE NEED SOME KIND OF STATEMENT REGARDING THIS. 2. WHITE STICKY MATTER DETECTED INSIDE THREE BAGS CONTAINING SYRINGES. IT DOES NOT SEEM TO BE PAINT, SINCE IT IS STILL STICKY OCH WILL NOT DRY. WE NEED YOU TO CONFIRM WHAT THIS MATTER IS, SINCE SYRINGES FROM OTHER PARTS ALREADY HAVE BEEN USED IN TWO BATCHES OF PHARMACEUTICALS READY FOR RELEASE AT OUR SITE. HOPEFULLY THIS IS AN ISOLATED HAPPENING DURING YOUR PRODUCTION OR PACKING PROCESS, ONLY AFFECTING THESE FEW BAGS OF SYRINGES, BUT WE NEED YOU TO CONFIRM THIS AS WELL.