BD 17GX3.5IN WEISS,19G SPIROL CE,5ML LOR LL
Received Nov 22, 2019 · Event occurred Oct 30, 2019
Report 1625685-2019-00131 · MDR key 9364923
Device
Product problems
- Break
- Failure to Deliver
- Break
- Failure to Deliver
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A CRACK AT THE TOP OF SYRINGE NEXT TO THE LUER LOCK WITH A BD 17GX3.5IN WEISS,19G SPIROL CE,5ML LOR LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD LAST WEEK WITH AN EPIDURAL TRAY. WHEN THE ANESTHESIOLOGIST WAS TRYING TO INJECT THE CATHETER HE SAID THERE WAS NO PRESSURE WITHIN THE SYRINGE. HE LOOKED AT IT CLOSELY AND SAW THERE WAS A CRACK AROUND THE TOP OF IT. WHEN HE TOOK IT IN TO SHOW THE L&D NURSE MANAGER THE SYRINGE COMPLETELY BROKE AROUND THE TOP WHERE THE METAL LUER LOCK IS. WE HAVE HAD MULTIPLE ISSUES WITH THIS TRAY SUCH AS NOT HAVING THE EPIDURAL NEEDLE. THE REF # 400835 AND THE LOT # 0001286611. UPDATED INFORMATION PROVIDED: THE GLASS SYRINGE HAD A CRACK AT THE TOP NEXT TO THE METAL LUER LOCK. IT WOULDN'T GIVE ANY RESISTANCE SO THE ANESTHESIOLOGIST OPENED ANOTHER TRAY. WHEN HE WENT TO SHOW THE MANAGER THE SYRINGE BROKE OFF AT THE TOP. THERE WAS NO PATIENT HARM BUT COULD HAVE CAUSED HARM IF THE DOCTOR HAD NOT SEEN THE CRACK.
Additional Manufacturer Narrative
H.6. INVESTIGATION SUMMARY ONE PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PROVIDED SAMPLE, THE SYRINGE WAS OBSERVED BROKEN INTO TWO PIECES. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE PROVIDED LOT NUMBER. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS. BASED ON THE INVESTIGATION RESULTS, A DEFINITIVE CAUSE FOR THIS INCIDENT COULD NOT BE DETERMINED. THE GLASS SYRINGE IS RECEIVED FROM A SUPPLIER ENTITY AND A NOTIFICATION HAS BEEN ISSUED TO THE SUPPLIER REGARDING THIS INCIDENT. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE PRODUCTION AND COMPLAINT PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT THERE WAS A CRACK AT THE TOP OF SYRINGE NEXT TO THE LUER LOCK WITH A BD 17GX3.5IN WEISS,19G SPIROL CE,5ML LOR LL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAD LAST WEEK WITH AN EPIDURAL TRAY. WHEN THE ANESTHESIOLOGIST WAS TRYING TO INJECT THE CATHETER HE SAID THERE WAS NO PRESSURE WITHIN THE SYRINGE. HE LOOKED AT IT CLOSELY AND SAW THERE WAS A CRACK AROUND THE TOP OF IT. WHEN HE TOOK IT IN TO SHOW THE L&D NURSE MANAGER THE SYRINGE COMPLETELY BROKE AROUND THE TOP WHERE THE METAL LUER LOCK IS. WE HAVE HAD MULTIPLE ISSUES WITH THIS TRAY SUCH AS NOT HAVING THE EPIDURAL NEEDLE. THE REF # 400835 AND THE LOT # 0001286611. UPDATED INFORMATION PROVIDED: THE GLASS SYRINGE HAD A CRACK AT THE TOP NEXT TO THE METAL LUER LOCK. IT WOULDN¿T GIVE ANY RESISTANCE SO THE ANESTHESIOLOGIST OPENED ANOTHER TRAY. WHEN HE WENT TO SHOW THE MANAGER THE SYRINGE BROKE OFF AT THE TOP. THERE WAS NO PATIENT HARM BUT COULD HAVE CAUSED HARM IF THE DOCTOR HAD NOT SEEN THE CRACK.