BD¿ LUER-LOK SYRINGE
Report
- Report Number
- 1911916-2018-00098
- Event Type
- Malfunction
- Date Received
- March 9, 2018
- Date of Event
- February 15, 2018
- Report Date
- April 24, 2018
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
INVESTIGATION RESULTS: SAMPLES WERE RETURNED FOR EVALUATION. BD FOUND THAT IN THE PROVIDED SAMPLES THERE WERE 38 SAMPLES WITH BUBBLES, 28 SAMPLES WITH BROKEN PLUNGER RODS/BARRELS, 3 SAMPLES WITH RUBMARKS, 61 SAMPLES WITH MINOR MISSING PRINT, 23 SAMPLES WITH MAJOR MISSING PRINT, 20 BURNT FLANGES, 2 SAMPLES WITH FOREIGN MATTER IN THE FLUID PATH, 52 SAMPLES WITH EMBEDDED FOREIGN MATTER, 1 SAMPLE WITH A MISSING PLUNGER ROD, 6 SHORT SHOTS, 6 SAMPLES WITH INK DOTS AND 2 SAMPLES WITH GREASE ON THEM. FAILURE MODE WAS VERIFIED. BUBBLES ARE FORMED IN THE FOLLOWING WAY. VENTS ON MOLD PARTIALLY PLUGGED WITH PLASTIC GAS DISCHARGE PREVENTING/OBSTRUCTING PRIMARY VENT DISCHARGE OR MOLD MELT DISK PROBES PARTIALLY OBSTRUCTED WHICH CREATES A JETTING EFFECT IN THE PLASTIC FLOW. IN TURN, THIS CREATES HEAD AND UNEVEN FLOW THROUGH THE GATES AND CAUSES BUBBLES. MOLD MELT DISK, GATES, AND VENTS ARE CLEANED. BUBBLES HAVE A LOW DEFECT RATE THAT DOES NOT AFFECT THE FUNCTION OR CAUSE LEAKAGE. BROKEN PLUNGER RODS AND BARRELS CAN BE CAUSED WHEN THEY ARE FED THROUGH A CHUTE TO THE ASSEMBLY PROCESS. IF THE CHUTE IS EMPTY, THE PLUNGER RODS AND BARRELS CAN EXPERIENCE EXCESSIVE FORCE WHEN FALLING THROUGH THE ENTIRE CHUTE. IT IS ALSO POSSIBLE THAT THERE WAS A MISALIGNMENT FROM A JAM ON THE METRO CAUSING DAMAGE. A SENSOR WAS INSTALLED ON THE CHUTE TO DETERMINE IF THE CHUTE IS EMPTY. WHEN THE CHUTE IS FULL, THE PARTS DO NOT SLIDE THE ENTIRE LENGTH OF THE CHUTE AND HAVE A REDUCED RISK OF DAMAGE. THE SENSOR WILL NOT ALLOW PARTS TO AUTOMATICALLY FEED INTO THE CHUTE UNLESS IT IS FULL. IF THERE IS A JAM IN THE METRO OPERATOR IS INSTRUCTED TO REMOVE AND CLEAN AREA ADJUST METRO IF NEEDED AND START STAT SAMPLE OF PRODUCT. A RUBMARK IS LIKELY CAUSED BY A BARREL OR PLUNGER ROD GETTING CAUGHT IN THE MACHINERY AND MAKING CONTACT WITH SYRINGES AS THEY ARE BEING PROCESSED. A CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) WAS INITIATED TO DETERMINE ROOT CAUSE AND IMPLEMENT CORRECTIVE ACTION TO REDUCE/ MITIGATE OCCURRENCE OF THIS ISSUE. MINOR MISSING PRINT- MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER, OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE. FOREIGN MATTER IN THE FLUID PATH CAN BE CAUSED WHEN PLASTIC DUST IS CREATED THROUGHOUT THE MANUFACTURING PROCESS VIA CONVEYING AND VIBRATION OF PLASTIC COMPONENTS. MACHINERY IS CLEANED MULTIPLE TIMES EACH DAY. ALL OPERATORS FOLLOW A GOWNING PROCEDURE TO REDUCE FOREIGN MATTER BROUGHT INTO THE MANUFACTURING AREA. ALL SYRINGES HAVE THE INTERIOR FLUSHED WITH IONIZED AIR TO REMOVE ANY POTENTIAL FOREIGN MATERIALS. A TRAINING WAS IMPLEMENTED ON 10/19/17 FOR FOREIGN MATTER IN THE FLUID PATH WITH ALL ASSOCIATES. EMBEDDED FOREIGN MATTER CAN OCCUR AT THE STARTUP OF THE INJECTION MOLDING PROCESS. SOLIDIFIED RESIN WITHIN THE MOLD AND MOLDING PRESS MAY BECOME DISCOLORED OR DEGRADED WHEN REHEATED. WHEN STARTING THE MOLDING PROCESS, THE PRESS IS PUT INTO "STARTUP" WHERE THE PRESS RUNS UNTIL ANY POTENTIAL FOREIGN MATTER IS FLUSHED THROUGH THE SYSTEM. THE PRESS REMAINS IN STARTUP UNTIL NO FOREIGN MATTER IS DETECTED IN INSPECTIONS. EMBEDDED FOREIGN MATTER CAN BE CAUSED WHEN A MOLDING PRESS ALSO FAULTS AND ALARMS. IF THE CONVEYOR IS NOT REVERSED BY THE TECH WHEN CLEARING THE ALARM, THE DEFECTIVE PRODUCT CAN GET INTO PRODUCTION. A TRAINING WAS IMPLEMENTED ON 11/15/17 FOR EMBEDDED FOREIGN MATTER WITH ALL ASSOCIATES. ROOT CAUSE FOR THE MISSING PLUNGER ROD IS UNDETERMINED HOWEVER, UPGRADED CAMERAS WERE INSTALLED ON LINES ON (7/15-7/16) AND USE UPDATED MODERN IMAGING AND PROGRAMMING TO DETECT MISSING STOPPERS ON PLUNGER ROD. THE CAMERA IS CHALLENGED EVERY SHIFT TO ENSURE IT IS FUNCTIONING AS INTENDED, SHOULD SYRINGE BE DETECTED WITH NO STOPPER, SYRINGE WILL BE EJECTED OFF OF MACHINE INTO WASTE TUB. SHORT SHOTS ARE CAUSED WHEN THE PART NOT PACKING OUT COMPLETELY DUE TO LOW PACK PRESSURE AND TIME. WE INCREASE OF PACK PRESSURE AND 2ND STAGE PACK TIME IS ADJUSTED WHEN THIS TYPE OF DEFECT OCCURS. INSPECTIONS ARE PERFORMED EVERY 4 HOURS ON 1 COMPLETE SHOT (24 PARTS) IF FOUND STAT SAMPLE IS PERFORMED AND REJECTED PRODUCT IS PUT ON HOLD FOR DISPOSITION. INK DOTS CAN OCCUR AFTER THE GRADUATION SCALE PRINTING PROCESS. DURING TRANSPORT BETWEEN THE PRINTING, ASSEMBLY, AND PACKAGING PROCESSES, SYRINGES CAN MAKE CONTACT WITH EACH OTHER. IT IS POSSIBLE THAT DURING CONTACT, INK FROM THE GRADUATION SCALE CAN TRANSFER BETWEEN SYRINGES CAUSING DOTS OF INK. A CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) WAS INITIATED TO DETERMINE ROOT CAUSE AND IMPLEMENT CORRECTIVE ACTION TO REDUCE/ MITIGATE OCCURRENCE OF THIS ISSUE. GREASE FOUND ON THE PRODUCT OCCURS BECAUSE DURING THE PRINTING PROCESS, THE SYRINGE RIDES ON CHAINS. THE CHAINS ARE OILED TO PRESERVE THE FUNCTION AND IMPROVE THE LIFE OF THE CHAINS. WHEN THE CHAINS ARE OILED, IT IS POSSIBLE THAT EXCESS OIL WAS APPLIED AND IF NOT CLEANED PROPERLY IT CAN CONTAMINATE THE SYRINGE. AUDITS ARE PERFORMED WEEKLY TO IDENTIFY IF CLEANING OF THE CHAINS IS REQUIRED. RETRAINING TO ALL OPERATORS, MECHANICS, AND TECHNICIANS TO REMIND THEM TO NOT OVERGREASE/OIL THE PRINTING CHAINS AND AVOID CONTAMINATING SYRINGES WAS PERFORMED 8/1/2017. 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. CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BUBBLES-38 BROKEN PLUNGER ROD AND BARREL-28 RUBMARKS-3 MINOR MISSING PRINT-61, 23 MAJOR BURNT FLANGES-20 FOREIGN MATTER IN FLUID PATH-2 EMBEDDED FOREIGN MATTER-52 MISSING PLUNGER ROD-1 SHORT SHOTS-6 INK DOTS-6 GREASE-2 A DEVICE HISTORY REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. COMPLAINT# 299104-COMPLAINT FOR DAMAGE, BLACK MARKS, WHITE MARKS, BAD PRINT, FAULTY MOLDING 7143802- PRODUCED ON 6/6/17 WITH OVERFLOW BATCHES 7086818, 7086790, 7143802 THERE WERE ZERO DEFECTS FOUND IN DHR¿S 7206977- PRODUCED ON 8/28/17 WITH OVERFLOW BATCHES 7180647, 7180641 THERE WERE ZERO DEFECTS FOUND IN DHR¿S 7179903- PRODUCED ON 8/6/17 THERE WERE ZERO DEFECTS FOUND IN DHR 6237689- PRODUCED ON 9/8/16 THERE WERE ZERO DEFECTS FOUND IN DHR 5236839- PRODUCED ON 9/30/15 THERE WERE ZERO DEFECTS FOUND IN DHR 7143827- PRODUCED ON 6/29/17 THERE WERE ZERO DEFECTS FOUND IN DHR 5356780- PRODUCED ON 1/31/16 THERE WERE ZERO DEFECTS FOUND IN DHR 7080809- PRODUCED ON 9/1/17 WITH OVERFLOW BATCHES 7055875, 7055874, 7055870, 7055869, 7055865, 7055868 THERE WERE ZERO DEFECTS FOUND IN DHR¿S 7051551- PRODUCED ON 3/29/17 THERE WERE ZERO DEFECTS FOUND IN DHR 7080823- PRODUCED ON 4/27/17 THERE WERE ZERO DEFECTS FOUND IN DHR 7023535- PRODUCED ON 3/2/17 THERE WERE ZERO DEFECTS FOUND IN DHR 6237706- PRODUCED ON 9/30/16 THERE WERE ZERO DEFECTS FOUND IN DHR BUBBLES- VENTS ON MOLD PARTIALLY PLUGGED WITH PLASTIC GAS DISCHARGE PREVENTING/OBSTRUCTING PRIMARY VENT DISCHARGE OR MOLD MELT DISK PROBES PARTIALLY OBSTRUCTED WHICH CREATES A JETTING EFFECT IN THE PLASTIC FLOW. IN TURN, THIS CREATES HEAD AND UNEVEN FLOW THROUGH THE GATES AND CAUSES BUBBLES. ---- BROKEN PLUNGER ROD AND BARREL- PLUNGER RODS AND BARRELS ARE FED THROUGH A CHUTE TO THE ASSEMBLY PROCESS. IF THE CHUTE IS EMPTY, THE PLUNGER RODS AND BARRELS CAN EXPERIENCE EXCESSIVE FORCE WHEN FALLING THROUGH THE ENTIRE CHUTE. IT IS ALSO POSSIBLE THAT THERE WAS A MISALIGNMENT FROM A JAM ON THE METRO CAUSING DAMAGE. --- RUBMARKS- A RUBMARK IS LIKELY CAUSED BY A BARREL OR PLUNGER ROD GETTING CAUGHT IN THE MACHINERY AND MAKING CONTACT WITH SYRINGES AS THEY ARE BEING PROCESSED. --- MINOR MISSING PRINT- MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER, OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE. --- BURNT FLANGES- BURNS CAN BE CAUSED WHEN THERE IS BLOCKAGE IN THE MOLD VENTS/ GATES WHICH CAN CAUSE BURNS ON THE FLANGE OF THE SYRINGE DURING MOLDING PROCESS. --- FOREIGN MATTER IN FLUID PATH- PLASTIC DUST MAY BE CREATED THROUGHOUT THE MANUFACTURING PROCESS VIA CONVEYING AND VIBRATION OF PLASTIC COMPONENTS. --- EMBEDDED FOREIGN MATTER- EMBEDDED FM CAN OCCUR AT THE STARTUP OF THE INJECTION MOLDING PROCESS. SOLIDIFIED RESIN WITHIN THE MOLD AND MOLDING PRESS MAY BECOME DISCOLORED OR DEGRADED WHEN REHEATED. --- MISSING PLUNGER ROD-UNCLEAR IF THIS WAS RECEIVED BY CUSTOMER OR WAS REMOVED AFTER. --- SHORT SHOTS- PART NOT PACKING OUT COMPLETELY DUE TO LOW PACK PRESSURE AND TIME. --- INK DOTS- INK DOTS CAN OCCUR AFTER THE GRADUATION SCALE PRINTING PROCESS. DURING TRANSPORT BETWEEN THE PRINTING, ASSEMBLY, AND PACKAGING PROCESSES, SYRINGES CAN MAKE CONTACT WITH EACH OTHER. IT IS POSSIBLE THAT DURING CONTACT, INK FROM THE GRADUATION SCALE CAN TRANSFER BETWEEN SYRINGES CAUSING DOTS OF INK. --- GREASE- DURING THE PRINTING PROCESS, THE SYRINGE RIDES ON CHAINS. THE CHAINS ARE OILED TO PRESERVE THE FUNCTION AND IMPROVE THE LIFE OF THE CHAINS. WHEN THE CHAINS ARE OILED, IT IS POSSIBLE THAT EXCESS OIL WAS APPLIED AND IF NOT CLEANED PROPERLY IT CAN CONTAMINATE THE SYRINGE. RUBMARKS- CAPA88318 WAS INITIATED TO DETERMINE ROOT CAUSE AND IMPLEMENT CORRECTIVE ACTION TO REDUCE/ MITIGATE OCCURRENCE OF THIS ISSUE. --- INK DOTS-CAPA 76365 HAS BEEN OPENED TO IMPROVE THE INK CURING PROCESS AND REDUCE CONTACT BETWEEN SYRINGES TO MITIGATE INK DOT ISSUES. ACTIONS TAKEN TO MITIGATE REPORTED DEFECTS. BUBBLES- MOLD MELT DISK, GATES, AND VENTS ARE CLEANED. BUBBLES HAVE A LOW DEFECT RATE THAT DOES NOT AFFECT THE FUNCTION OR CAUSE LEAKAGE. ---- BROKEN PLUNGER ROD AND BARREL- A SENSOR WAS INSTALLED ON THE CHUTE TO DETERMINE IF THE CHUTE IS EMPTY. WHEN THE CHUTE IS FULL, THE PARTS DO NOT SLIDE THE ENTIRE LENGTH OF THE CHUTE AND HAVE A REDUCED RISK OF DAMAGE. THE SENSOR WILL NOT ALLOW PARTS TO AUTOMATICALLY FEED INTO THE CHUTE UNLESS IT IS FULL. IF THERE IS A JAM IN THE METRO OPERATOR IS INSTRUCTED TO REMOVE AND CLEAN AREA ADJUST METRO IF NEEDED AND START STAT SAMPLE OF PRODUCT. --- MINOR MISSING PRINT-NOT REQUIRED --- BURNT FLANGES- REMEDIED BY CHANGING THE PROCESS PARAMETERS WITHIN VALIDATED STATE. SINCE IMMEDIATE CORRECTIVE ACTIONS ARE EFFECTIVE AT ALLEVIATING THE BURNS THERE ARE NO LONG TERM CORRECTIVE ACTIONS NECESSARY. CURRENT CONTROLS ARE IN PROCESS REPAIRS OR SHUTTING DOWN PRESS IF LOW CAVITATION THRESHOLD IS MET. --- FOREIGN MATTER IN FLUID PATH- MACHINERY IS CLEANED MULTIPLE TIMES EACH DAY. ALL OPERATORS FOLLOW A GOWNING PROCEDURE TO REDUCE FM BROUGHT INTO THE MANUFACTURING AREA. ALL SYRINGES HAVE THE INTERIOR FLUSHED WITH IONIZED AIR TO REMOVE ANY POTENTIAL FOREIGN MATERIALS. A TRAINING WAS IMPLEMENTED ON 10/19/17 FOR FM IN THE FLUID PATH WITH ALL ASSOCIATES. --- EMBEDDED FOREIGN MATTER- WHEN STARTING THE MOLDING PROCESS, THE PRESS IS PUT INTO "STARTUP" WHERE THE PRESS RUNS UNTIL ANY POTENTIAL FM IS FLUSHED THROUGH THE SYSTEM. THE PRESS REMAINS IN STARTUP UNTIL NO FM IS DETECTED IN INSPECTIONS. EMFM CAN BE CAUSED WHEN A MOLDING PRESS ALSO FAULTS AND ALARMS. IF THE CONVEYOR IS NOT REVERSED BY THE TECH WHEN CLEARING THE ALARM, THE DEFECTIVE PRODUCT CAN GET INTO PRODUCTION. A TRAINING WAS IMPLEMENTED ON 11/15/17 FOR EMFM WITH ALL ASSOCIATES. --- MISSING PLUNGER ROD- UPGRADED CAMERAS WERE INSTALLED ON LINES ON (7/15-7/16) AND USE UPDATED MODERN IMAGING AND PROGRAMMING TO DETECT MISSING STOPPERS ON PLUNGER ROD. THE CAMERA IS CHALLENGED EVERY SHIFT TO ENSURE IT IS FUNCTIONING AS INTENDED, SHOULD SYRINGE BE DETECTED WITH NO STOPPER, SYRINGE WILL BE EJECTED OFF OF MACHINE INTO WASTE TUB. --- SHORT SHOTS- INCREASE OF PACK PRESSURE AND 2ND STAGE PACK TIME IS ADJUSTED WHEN THIS TYPE OF DEFECT OCCURS. INSPECTIONS ARE PERFORMED EVERY 4 HOURS ON 1 COMPLETE SHOT (24 PARTS) IF FOUND STAT SAMPLE IS PERFORMED AND REJECTED PRODUCT IS PUT ON HOLD FOR DISPOSITION. --- GREASE- AUDITS ARE PERFORMED WEEKLY TO IDENTIFY IF CLEANING OF THE CHAINS IS REQUIRED. RETRAINING TO ALL OPERATORS, MECHANICS, AND TECHNICIANS TO REMIND THEM TO NOT OVERGREASE/OIL THE PRINTING CHAINS AND AVOID CONTAMINATING SYRINGES WAS PERFORMED 8/1/2017.
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 #: 7143802. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2017-05-23. MEDICAL DEVICE LOT #: 7206977. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2017-07-25. MEDICAL DEVICE LOT #: 7179903. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. DEVICE MANUFACTURE DATE: 2017-06-28. MEDICAL DEVICE LOT #: 6237689. MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2016-08-24. MEDICAL DEVICE LOT #: 5236839. MEDICAL DEVICE EXPIRATION DATE: 2020-08-31. DEVICE MANUFACTURE DATE: 2015-08-24. MEDICAL DEVICE LOT #: 7143827. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2017-05-23. MEDICAL DEVICE LOT #: 7080809. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2017-03-21. MEDICAL DEVICE LOT #: 7051551. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2017-02-20. MEDICAL DEVICE LOT #: 7080823. MEDICAL DEVICE EXPIRATION DATE: 2022-03-31. DEVICE MANUFACTURE DATE: 2017-03-21. MEDICAL DEVICE LOT #: 7023535. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2017-01-23. MEDICAL DEVICE LOT #: 6237706 MEDICAL DEVICE EXPIRATION DATE: 2021-08-31. DEVICE MANUFACTURE DATE: 2016-08-24. MEDICAL DEVICE LOT #: 5356780. MEDICAL DEVICE EXPIRATION DATE: 2020-12-31. DEVICE MANUFACTURE DATE: 2015-12-22. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT MULTIPLE DEFECTS, INCLUDING CRACKED/DAMAGED SYRINGES, MISSING MARKINGS, ETC., WERE OBSERVED ON SEVERAL LOTS OF BD LUER-LOK¿ SYRINGE(S). THESE DEFECTS WERE FOUND BEFORE USE AND THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172099 | BD¿ LUER-LOK SYRINGE | HYPODERMIC SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |