BD¿ ORAL DISPENSING SYRINGE 3 ML
Report
- Report Number
- 1213809-2021-00837
- Event Type
- Malfunction
- Date Received
- January 4, 2022
- Date of Event
- December 7, 2021
- Report Date
- December 15, 2021
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- KYW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. EACH PHOTO SHOWED A LOOSE 3ML ORAL SYRINGE (P/N 305210) WITH FLUID PRESENT IN THE TIP WHEN THE PLUNGER-STOPPER ASSEMBLY WAS BOTTOMED OUT. THE LIQUID OBSERVED APPEARED TO BE SILICONE LUBRICANT USED IN THE MANUFACTURING PROCESS AND CONFIRMED BY CUSTOMER SUPPLIED FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS. THE OBSERVED AMOUNT OF LUBRICANT WAS NON-CONFORMING PER PRODUCT SPECIFICATION. TECHNICIAN LOGS AND PRODUCTION DATABASES WERE REVIEWED AS PART OF THIS INVESTIGATION. IT WAS NOTED THAT DURING ONE OF THE SUB-ASSEMBLY BATCHES SEVERAL ADJUSTMENTS NEEDED TO BE MADE TO THE SILICONE SENSOR AND ENCODER. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS LIKELY THE ISSUES ENCOUNTERED WITH THE SILICONE SYSTEM DURING THE SUB-ASSEMBLY PROCESS LED TO THE DEFECT BEING PRODUCED AND INTRODUCED INTO THE PACKAGING MACHINE. THE AQL FOR EXCESSIVE SILICONE IS 1.0%. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 390,000 WHICH IS 0.0003%. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1082858 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. EACH PHOTO SHOWED A LOOSE 3ML ORAL SYRINGE (P/N (B)(4) WITH FLUID PRESENT IN THE TIP WHEN THE PLUNGER-STOPPER ASSEMBLY WAS BOTTOMED OUT. THE LIQUID OBSERVED APPEARED TO BE SILICONE LUBRICANT USED IN THE MANUFACTURING PROCESS AND CONFIRMED BY CUSTOMER SUPPLIED FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS. THE OBSERVED AMOUNT OF LUBRICANT WAS NON-CONFORMING PER PRODUCT SPECIFICATION. TECHNICIAN LOGS AND PRODUCTION DATABASES WERE REVIEWED AS PART OF THIS INVESTIGATION. IT WAS NOTED THAT DURING ONE OF THE SUB-ASSEMBLY BATCHES SEVERAL ADJUSTMENTS NEEDED TO BE MADE TO THE SILICONE SENSOR AND ENCODER. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. THE SILICONE APPLICATION PROCESS IS DESIGNED TO PROVIDE AN EVEN DISTRIBUTION OF SILICONE ON THE INTERIOR OF THE SYRINGE BARREL. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS LIKELY THE ISSUES ENCOUNTERED WITH THE SILICONE SYSTEM DURING THE SUB-ASSEMBLY PROCESS LED TO THE DEFECT BEING PRODUCED AND INTRODUCED INTO THE PACKAGING MACHINE. THE AQL FOR EXCESSIVE SILICONE IS 1.0%. THE DEFECTIVE RATE IDENTIFIED IS 1 OUT OF 390,000 WHICH IS 0.0003%. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #1082858 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT THE BD¿ ORAL DISPENSING SYRINGE 3 ML EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FOUND A SYRINGE THAT HAD FLUID INSIDE THE TIP OF THE SYRINGE. AN FTIR WAS CARRIED OUT ON THE LIQUID WHICH IS HOW WE DISCERNED IT WAS SILICONE.
IT WAS REPORTED THAT THE BD¿ ORAL DISPENSING SYRINGE 3 ML EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE FOUND A SYRINGE THAT HAD FLUID INSIDE THE TIP OF THE SYRINGE. AN FTIR WAS CARRIED OUT ON THE LIQUID WHICH IS HOW WE DISCERNED IT WAS SILICONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1269545 | BD¿ ORAL DISPENSING SYRINGE 3 ML | LIQUID MEDICATION DISPENSER | KYW | BECTON DICKINSON MEDICAL SYSTEMS | 1082858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |