BD SYRINGE LUER-LOK¿ TIP
Report
- Report Number
- 1213809-2018-00084
- Event Type
- Malfunction
- Date Received
- March 7, 2018
- Date of Event
- February 14, 2018
- Report Date
- March 15, 2018
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903029953
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
AS PER REQUEST, FTIR ANALYSIS WAS COMPLETED ON THE EXCESS SILICONE SEEN IN THE SAMPLES FROM LOT # 7212586. A SMALL AMOUNT OF CLEAR MATERIAL SEEN THE IN THE BARREL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS CONFIRMS THAT THIS MATERIAL IS SILICONE.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8002645; MEDICAL DEVICE EXPIRATION DATE: 2022-12-31; DEVICE MANUFACTURE DATE: 2018-01-02; MEDICAL DEVICE LOT #: 7212586 ; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2017-07-31; MEDICAL DEVICE LOT #: 6322711; MEDICAL DEVICE EXPIRATION DATE: 2021-11-30; DEVICE MANUFACTURE DATE: 2016-11-17; MEDICAL DEVICE LOT #: 7236572 ; MEDICAL DEVICE EXPIRATION DATE: 2022-07-31; DEVICE MANUFACTURE DATE: 2017-08-24; MEDICAL DEVICE LOT #: 7333949; MEDICAL DEVICE EXPIRATION DATE: 2022-11-30; DEVICE MANUFACTURE DATE: 2017-11-29; INVESTIGATION SUMMARY: (B)(4) OPEN 10ML PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCHES #8002645, 7236572, 6322711 AND 7212586 (P/N 302995). THE SAMPLES WERE VISUALLY EVALUATED. ONLY ONE BATCH 7212586 (TWO SYRINGES) ¿ THE SYRINGES WERE FOUND TO HAVE EXCESS SILICONE CONTENT PER SPECIFICATION. DHR REVIEW WAS CONDUCTED ON ALL FIVE BATCHES AND NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. ADDITIONALLY, DHR REVIEW FOR BATCH #7212586 (P/N 302995) INDICATED THAT SILICONE WEIGHT TESTING WAS PERFORMED AS PER REQUIREMENT WITH ALL TEST RESULTS WITHIN ACCEPTABLE RANGE PER PRODUCT SPECIFICATION. BATCH 7212586 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. POTENTIAL ROOT CAUSE: INVESTIGATION REVEALED SILICONE GUN ADJUSTMENTS WERE PERFORMED SHORTLY AFTER THE MANUFACTURING TIME OF BATCH #7212586. IT IS POSSIBLE THE GUN WAS MALFUNCTIONING DURING THE MANUFACTURE OF BATCH 7212586 AFFECTING A LIMITED NUMBER OF BARRELS. THE AQL AT BD (B)(4) FOR EXCESS SILICONE PRESENCE IS (B)(4). COMPLAINT HISTORY CHECK REVEALS 2 OTHER COMPLAINTS AGAINST BATCH #7212586 WITH 3 CONFIRMED SYRINGES FOR EXCESS SILICONE IN THOSE COMPLAINTS. ASSUMING THAT THE ADDITIONAL (B)(4) SAMPLES REPORTED FOR THIS COMPLAINT WERE FOUND TO HAVE EXCESS SILICONE IN ACCORDANCE WITH THE GUIDELINE PROVIDED BY BD (B)(4), THE TOTAL NUMBER OF AFFECTED PIECES IS THEREFORE 62+2+3 = 67. THE DEFECTIVE RATE FOR THE BATCH IS (B)(4), WHICH IS WELL WITHIN THE AQL. CORRECTIVE ACTIONS: MACHINE ADJUSTMENTS TO SILICONE GUN WERE MADE AFTER BATCH #7212586 WAS COMPLETE. CURRENT PRODUCTION WAS EVALUATED AND THE ASSEMBLY MACHINE INSPECTED. EACH SILICONE GUN WAS CONFIRMED TO RUN WITHIN PRODUCTION SPECIFICATION WITH NO ISSUES. NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. PLEASE NOTE THAT 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. BD APPLIES SILICONE TO OUR SYRINGES UNDER CAREFULLY CONTROLLED CONDITIONS THAT ARE MONITORED FOR COMPLIANCE TO BOTH BD STANDARDS AS WELL AS MEETING THE REQUIREMENTS OF THE ISO STANDARD FOR SYRINGES - ISO 7886-1. 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. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION SAMPLE EVALUATION: (B)(4) OPEN 10ML PACKAGED SYRINGES WERE RECEIVED BY BD (B)(4) AND CONFIRMED TO BE FROM BATCHES #8002645, 7236572, 6322711 AND 7212586 (P/N 302995). THE SAMPLES WERE VISUALLY EVALUATED. BATCH 8002645 (TWO SYRINGES) ¿ THE SYRINGES WERE FOUND TO HAVE ACCEPTABLE SILICONE CONTENT PER SPECIFICATION. BATCH 6322711 (ONE SYRINGE) ¿ THE SYRINGE WAS FOUND TO HAVE ACCEPTABLE SILICONE CONTENT PER SPECIFICATION. BATCH 7236572 (ONE SYRINGE) ¿ THE SYRINGE WAS FOUND TO HAVE ACCEPTABLE SILICONE CONTENT PER SPECIFICATION. BATCH 7212586 (TWO SYRINGES) ¿ THE SYRINGES WERE FOUND TO HAVE EXCESS SILICONE CONTENT PER SPECIFICATION. DHR REVIEW FOR BATCH #8002645 (P/N 302995): MANUFACTURING DATES: 1/12/2018 ¿ 1/13/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8002645 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH #6322711 (P/N 302995): MANUFACTURING DATES: 12/23/2016 ¿ 12/27/2016. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6322711 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH #7236572 (P/N 302995): MANUFACTURING DATES: 9/01/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7236572 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH #7333949 (P/N 302995): MANUFACTURING DATES: 12/03/2017 ¿ 12/04/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7333949 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH #7212586 (P/N 302995): MANUFACTURING DATES: 08/17/2017 TO 08/21/2017. BATCH QUANTITY WAS (B)(4). ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. SILICONE WEIGHT TESTING WAS PERFORMED AS PER REQUIREMENT WITH ALL TEST RESULTS WITHIN ACCEPTABLE RANGE PER PRODUCT SPECIFICATION. BATCH 7212586 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. POTENTIAL ROOT CAUSE: INVESTIGATION REVEALED SILICONE GUN ADJUSTMENTS WERE PERFORMED SHORTLY AFTER THE MANUFACTURING TIME OF BATCH #7212586. IT IS POSSIBLE THE GUN WAS MALFUNCTIONING DURING THE MANUFACTURE OF BATCH 7212586 AFFECTING A LIMITED NUMBER OF BARRELS. THE AQL AT BD (B)(4) FOR EXCESS SILICONE PRESENCE IS (B)(4). COMPLAINT HISTORY CHECK REVEALS 2 OTHER COMPLAINTS AGAINST BATCH #7212586 WITH 3 CONFIRMED SYRINGES FOR EXCESS SILICONE IN THOSE COMPLAINTS. ASSUMING THAT THE ADDITIONAL (B)(4) SAMPLES REPORTED FOR THIS COMPLAINT WERE FOUND TO HAVE EXCESS SILICONE IN ACCORDANCE WITH THE GUIDELINE PROVIDED BY BD (B)(4), THE TOTAL NUMBER OF AFFECTED PIECES IS THEREFORE 62+2+3 = 67. THE DEFECTIVE RATE FOR THE BATCH IS (B)(4), WHICH IS WELL WITHIN THE AQL. CORRECTIVE ACTIONS: MACHINE ADJUSTMENTS TO SILICONE GUN WERE MADE AFTER BATCH #7212586 WAS COMPLETE. CURRENT PRODUCTION WAS EVALUATED AND THE ASSEMBLY MACHINE INSPECTED. EACH SILICONE GUN WAS CONFIRMED TO RUN WITHIN PRODUCTION SPECIFICATION WITH NO ISSUES. NO ADDITIONAL ACTIONS ARE REQUIRED AT THIS TIME. PLEASE NOTE THAT 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. BD APPLIES SILICONE TO OUR SYRINGES UNDER CAREFULLY CONTROLLED CONDITIONS THAT ARE MONITORED FOR COMPLIANCE TO BOTH BD STANDARDS AS WELL AS MEETING THE REQUIREMENTS OF THE ISO STANDARD FOR SYRINGES - ISO 7886-1. 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. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE SAMPLE EVALUATION: CONFIRMED FOR BATCH #7212586 ONLY: BD (B)(4) WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE. ROOT CAUSE DESCRIPTION. INVESTIGATION REVEALED SILICONE GUN ADJUSTMENTS WERE PERFORMED SHORTLY AFTER THE MANUFACTURING TIME OF BATCH #7212586. IT IS POSSIBLE THE GUN WAS MALFUNCTIONING DURING THE MANUFACTURE OF BATCH 7212586 AFFECTING A LIMITED NUMBER OF BARRELS.
IT WAS REPORTED THAT BEFORE USE, A BD SYRINGE LUER-LOK¿ TIP WAS FOUND WITH FOREIGN MATTER AS ¿THERE WAS AN OILY SUBSTANCE ON THE END OF THE SYRINGE¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 165504 | BD SYRINGE LUER-LOK¿ TIP | SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | SEE H.10 | 30382903029953 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |