BD LUER LOK 3 ML SYRINGE
Report
- Report Number
- 1213809-2019-01051
- Event Type
- Malfunction
- Date Received
- October 16, 2019
- Date of Event
- October 1, 2019
- Report Date
- December 18, 2019
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903097020
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION: NINE PHOTOS AND SEVENTY-FIVE 3ML SYRINGES (P/N 309702) WERE RECEIVED AND EVALUATED. FIFTY WERE IN A FULLY SEALED CONVENIENCE TRAYS WITH TWENTY-FIVE FROM BATCH 8274548 AND TWENTY-FIVE FROM BATCH 8274539. TWENTY-FIVE WERE IN THREE SEPARATE CLEAR PLASTIC BAGS. TEN WERE IN A BAG LABELLED WITH BATCH 8274539, TEN WERE IN A BAG LABELLED WITH BATCH 8274512, AND FIVE WERE IN A BAG LABELLED WITH BATCH 8274524. ALL THE SYRINGES IN THE BAGS WERE FILLED WITH 3ML OF CLEAR LIQUID (LIDOCAINE) AND WERE OBSERVED TO HAVE LEAKAGE PAST AT LEAST THE FIRST RIB OF THE STOPPER. THE UNUSED SYRINGES WERE DISASSEMBLED, AND EACH COMPONENT WAS VISUALLY INSPECTED. NO VISUAL DEFECTS WERE OBSERVED ON THE BARRELS, PLUNGER RODS OR STOPPERS. LEAKAGE PAST STOPPER TESTING WAS PERFORMED ON ALL FIFTY OF THE UNUSED SAMPLES PRIOR TO DISASSEMBLING. NO LEAKAGE WAS OBSERVED. ALL THE MOLD NUMBERS OF THE BARRELS AND PLUNGER RODS FROM THE USED SAMPLES WERE RECORDED AND ANALYZED. (B)(4). DIMENSIONAL ANALYSIS WAS PERFORMED ON ALL THE COLLECTED SAMPLES AND ALL WERE ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE LEAKAGE PAST STOPPER DEFECT IS UNDETERMINED. NO LEAKAGE OR VISUAL DEFECTS WERE OBSERVED ON ANY OF THE UNUSED SAMPLES RECEIVED. ADDITIONALLY, THE DIMENSIONAL ANALYSIS PERFORMED ON THE SAMPLES FROM THE ASSOCIATED MOLDS WERE ALL ACCEPTABLE PER PRODUCT SPECIFICATION. DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF ALL THE PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
IT WAS REPORTED THAT BD LUER LOK¿ 3 ML SYRINGE LEAKED BEFORE USE. THIS OCCURRED ON 688 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309702 BATCH NO. 8274539, 8274548, 8274512 AND 8274524. IT WAS REPORTED LEAKAGE HAS BEEN OBSERVED BEYOND THE SECOND RIB OF THE STOPPER AND INTO THE AREA EXPOSED TO AIR. "HI, I AM WRITING YOU TO REPORT THAT WE HAVE FOUND AN INCREASE IN 3ML SYRINGES WHERE A LEAKAGE HAS BEEN OBSERVED BEYOND THE SECOND RIB OF THE STOPPER AND INTO THE AREA EXPOSED TO AIR. PER OUR COMPANY PROCEDURES, WE NEED TO REPORT ANY UNUSUAL TREND OBSERVED AS PART OF OUR INVESTIGATION." 10/2/2019: REACHED OUT TO CUSTOMER VIA PHONE TO GATHER ADDITIONAL INFORMATION. CUSTOMER STATES THERE HAS BEEN NO PATIENT INVOLVEMENT AS THEY PREFILL THE SYRINGES AND INSPECT THEM BEFORE THEY REACH THE PATIENT. SHE PROVIDED THE DEFECTED QUANTITY'S FOUND FOR EACH LOT NUMBER. SAMPLES ARE AVAILABLE FOR INVESTIGATION AND PROVIDED ME WITH HER MAILING ADDRESS. THE SPECIFIC DATE THESE WERE FOUND IS UNKNOWN BUT THEY WERE FOUND BETWEEN (B)(6) 2019. ANSWERS RECVD FROM CUSTOMER BELOW 10/9/2019: Q: WHAT WAS THE ORDER QUANTITY FOR EACH OF THE REPORTED BATCHES INVOLVED? A: 50 CASES PER BATCH. Q: WAS THE DEFECT OBSERVED DURING INCOMING INSPECTION OR DURING PROCESSING? A: DEFECTS OBSERVED DURING PROCESSING (FILLING OR CAPPING OF SYRINGE AND DURING VISUAL INSPECTION). Q: HOW MANY PIECES WERE SAMPLED AND TESTED FOR THE REPORTED DEFECT TOTAL? A: WE DO BATCHES OF 1400 SYRINGES, AND EVERY SYRINGE IS VISUALLY INSPECTED. Q: PLEASE DESCRIBE THE METHOD OF TESTING USED? A: 100% VISUAL INSPECTION . Q: DO YOU HAVE UNUSED PHYSICAL SAMPLES FROM EACH REPORTED BATCH WHICH YOU COULD PROVIDE FOR EVALUATION? IF SO PLEASE USE THE SHIPPING LABEL. A: WE ARE SENDING 1 TRAY PACK OF ONE LOT AND 1 TRAY PACK OF ANOTHER LOT. WE DO NOT HAVE UNUSED SAMPLES FOR OTHER LOTS. ADDITIONAL QUESTIONS TO CUSTOMER SENT 10/10, RESPONSES BELOW: Q: IS IT POSSIBLE TO LINK THE PHOTOS PROVIDED TO THEIR CORRESPONDING BATCH NUMBERS? A: (THE SAME ISSUES HAPPEN WITH EACH LOT, THERE IS NO DIFFERENTIATION BETWEEN LOTS). Q: ARE THESE THE HIGHEST RESOLUTION PHOTOS YOU HAVE AVAILABLE? AS THE LEAKAGE CANNOT BE SEEN IN MANY. A: NOT EVERY SYRINGE HAS FLUID PAST THE SECOND STOPPER. THESE ARE THE NUMBERS THAT WE HAVE SEEN LIQUID PAST THE FIRST STOPPER OR SECOND STOPPER. IS IT OKAY TO STORE AND USE SYRINGES WHERE LIQUID HAS PAST THE FIRST STOPPER AS STATED IN THE NAN ALERT WITH 10ML SYRINGE. FOR EVERY LOT WE ARE EXPERIENCE THE SAME ISSUES¿IE THE LIQUID IS PAST THE FIRST STOPPER AND/OR PAST THE SECOND STOPPER. #3ML STOPPER ISSUE, 3ML BD LOT. Q: WHAT METHOD DO YOU USE FOR FILLING? I.E. AUTOMATED, MANUAL? A: WE ARE USING THE BAXA REPEATER PUMP TO INJECT 3ML INTO SYRINGE WE ARE USING BAXTER SYRINGE TIP CAP. Q: HOW LONG AFTER FILLING WERE THE SYRINGES INSPECTED FOR LEAKAGE PAST STOPPER? A: 100% VISUAL INSPECTION OCCURS 30MINS-2HOUR PAST FILLING OF EACH SYRINGE. Q: HOW ARE THE FILLED SYRINGES STORED? A: SYRINGES ARE STORED IN LIGHT PROTECTIVE BAG IN REFRIGERATOR. WE HAVE NOT ASSESSED OUR SYRINGES AFTER STORAGE IN THE REFRIGERATOR. WOULD WE NEED TO INSPECT THESE PRODUCTS AFTER THE SYRINGES PASSED THE 100% VISUAL INSPECTION (NO LIQUID PAST EITHER STOPPER)? PLEASE NOTE WE HAVE BEEN MAKING THIS PRODUCT FOR YEARS WITH THE SAME COMPONENTS AND HAVE NOT BEEN EXPERIENCING THIS ISSUE THAT WE HAVE BEEN SEEING SINCE AROUND AUGUST 1ST, 2019. Q: CAN YOU TELL ME WHAT MEDICATION YOU ALL ARE FILLING THESE SYRINGES WITH? A: BUFFERED LIDOCAINE 3ML (LIDOCAINE HCL 0.9%/ SODIUM BICARBONATE 0.84%).
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8274539. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-11-15. MEDICAL DEVICE LOT #: 8274548. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-22. MEDICAL DEVICE LOT #: 8274512. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-22. MEDICAL DEVICE LOT #: 8274524. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-22. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT BD LUER LOK¿ 3 ML SYRINGE LEAKED BEFORE USE. THIS OCCURRED ON 688 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309702 BATCH NO. 8274539, 8274548, 8274512 AND 8274524. IT WAS REPORTED LEAKAGE HAS BEEN OBSERVED BEYOND THE SECOND RIB OF THE STOPPER AND INTO THE AREA EXPOSED TO AIR. HI, I AM WRITING YOU TO REPORT THAT WE HAVE FOUND AN INCREASE IN 3ML SYRINGES WHERE A LEAKAGE HAS BEEN OBSERVED BEYOND THE SECOND RIB OF THE STOPPER AND INTO THE AREA EXPOSED TO AIR. PER OUR COMPANY PROCEDURES, WE NEED TO REPORT ANY UNUSUAL TREND OBSERVED AS PART OF OUR INVESTIGATION. (B)(6) 2019- REACHED OUT TO CUSTOMER VIA PHONE TO GATHER ADDITIONAL INFORMATION. CUSTOMER STATES THERE HAS BEEN NO PATIENT INVOLVEMENT AS THEY PREFILL THE SYRINGES AND INSPECT THEM BEFORE THEY REACH THE PATIENT. SHE PROVIDED THE DEFECTED QUANTITY'S FOUND FOR EACH LOT NUMBER. SAMPLES ARE AVAILABLE FOR INVESTIGATION AND PROVIDED ME WITH HER MAILING ADDRESS. THE SPECIFIC DATE THESE WERE FOUND IS UNKNOWN BUT THEY WERE FOUND BETWEEN (B)(6) 2019 THROUGH (B)(6) 2019. ANSWERS RECEIVED FROM CUSTOMER BELOW (B)(6) 2019: Q: WHAT WAS THE ORDER QUANTITY FOR EACH OF THE REPORTED BATCHES INVOLVED? A: 50 CASES PER BATCH. Q: WAS THE DEFECT OBSERVED DURING INCOMING INSPECTION OR DURING PROCESSING? A: DEFECTS OBSERVED DURING PROCESSING (FILLING OR CAPPING OF SYRINGE AND DURING VISUAL INSPECTION). Q: HOW MANY PIECES WERE SAMPLED AND TESTED FOR THE REPORTED DEFECT TOTAL? A: WE DO BATCHES OF 1400 SYRINGES, AND EVERY SYRINGE IS VISUALLY INSPECTED. Q: PLEASE DESCRIBE THE METHOD OF TESTING USED? A: 100% VISUAL INSPECTION. Q: DO YOU HAVE UNUSED PHYSICAL SAMPLES FROM EACH REPORTED BATCH WHICH YOU COULD PROVIDE FOR EVALUATION? IF SO PLEASE USE THE SHIPPING LABEL. A: WE ARE SENDING 1 TRAY PACK OF ONE LOT AND 1 TRAY PACK OF ANOTHER LOT. WE DO NOT HAVE UNUSED SAMPLES FOR OTHER LOTS. ADDITIONAL QUESTIONS TO CUSTOMER SENT 10/10, RESPONSES BELOW: Q: IS IT POSSIBLE TO LINK THE PHOTOS PROVIDED TO THEIR CORRESPONDING BATCH NUMBERS? A: (THE SAME ISSUES HAPPEN WITH EACH LOT, THERE IS NO DIFFERENTIATION BETWEEN LOTS). Q: ARE THESE THE HIGHEST RESOLUTION PHOTOS YOU HAVE AVAILABLE? AS THE LEAKAGE CANNOT BE SEEN IN MANY. A: NOT EVERY SYRINGE HAS FLUID PAST THE SECOND STOPPER. THESE ARE THE NUMBERS THAT WE HAVE SEEN LIQUID PAST THE FIRST STOPPER OR SECOND STOPPER. IS IT OKAY TO STORE AND USE SYRINGES WHERE LIQUID HAS PAST THE FIRST STOPPER AS STATED IN THE NAN ALERT WITH 10ML SYRINGE. FOR EVERY LOT WE ARE EXPERIENCING THE SAME ISSUES¿IE THE LIQUID IS PAST THE FIRST STOPPER AND/OR PAST THE SECOND STOPPER. #3ML STOPPER ISSUE, 3ML BD LOT. Q: WHAT METHOD DO YOU USE FOR FILLING? I.E. AUTOMATED, MANUAL? A: WE ARE USING THE BAXA REPEATER PUMP TO INJECT 3ML INTO SYRINGE WE ARE USING BAXTER SYRINGE TIP CAP. Q: HOW LONG AFTER FILLING WERE THE SYRINGES INSPECTED FOR LEAKAGE PAST STOPPER? A: 100% VISUAL INSPECTION OCCURS 30 MINUTES TO 2 HOURS PAST FILLING OF EACH SYRINGE. Q: HOW ARE THE FILLED SYRINGES STORED? A: SYRINGES ARE STORED IN LIGHT PROTECTIVE BAG IN REFRIGERATOR. WE HAVE NOT ASSESSED OUR SYRINGES AFTER STORAGE IN THE REFRIGERATOR. WOULD WE NEED TO INSPECT THESE PRODUCTS AFTER THE SYRINGES PASSED THE 100% VISUAL INSPECTION (NO LIQUID PAST EITHER STOPPER)? PLEASE NOTE WE HAVE BEEN MAKING THIS PRODUCT FOR YEARS WITH THE SAME COMPONENTS AND HAVE NOT BEEN EXPERIENCING THIS ISSUE THAT WE HAVE BEEN SEEING SINCE AROUND (B)(6), 2019. Q: CAN YOU TELL ME WHAT MEDICATION YOU ALL ARE FILLING THESE SYRINGES WITH? A: BUFFERED LIDOCAINE 3ML (LIDOCAINE HCL 0.9%/ SODIUM BICARBONATE 0.84%)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 993034 | BD LUER LOK 3 ML SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | SEE H.10 | 30382903097020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |