BD LUER LOK¿ SYRINGE WITH NEEDLE
Report
- Report Number
- 1213809-2018-00442
- Event Type
- Malfunction
- Date Received
- July 22, 2018
- Date of Event
- July 2, 2018
- Report Date
- August 14, 2018
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903095729
- PMA / PMN Number
- K980987
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
THREE HUNDRED SEALED 3ML PACKAGED SYRINGES WITH NEEDLES WERE RECEIVED AND CONFIRMED TO BE FROM BATCH #8010876 (P/N 309572). ONE BOX ALSO CONTAINED 15 PACKAGED 3ML SYRINGES NOT MANUFACTURED IN CANAAN. THE SYRINGES ARE 3ML NEEDLE PRODUCT FROM EXEL. THE 300 BD-SAMPLES WERE VISUALLY EVALUATED. THE SAMPLES WERE RECEIVED IN THREE SHELF CARTONS OF 100 SYRINGES. ONE BOX WAS TAPED CLOSED, THE TAPE APPEARED TO BE FROM MANUFACTURING PROCESS. THE SECOND BOX WAS TAPED CLOSED, THE TAPE APPEARED TO BE APPLIED OVER THE MANUFACTURING TAPE BY THE END USER. THE THIRD BOX WAS TAPED CLOSED WITH NARROW SCOTCH TAPE PERPENDICULAR TO THE MANUFACTURING TAPE ON THE SHELF BOX. ALL SYRINGES WERE SEALED NO VISUAL DEFECTS WERE OBSERVED. AFTER THE INITIAL EVALUATION WAS PERFORMED THE SAMPLES WERE REMOVED FROM PACKAGING FOR LEAK TESTING. SEE DETAILS BELOW. 300 BD-SYRINGES TESTED PER APPLICABLE PROCEDURE. LUER LEAKAGE TEST ¿ 300 SYRINGES TESTED WITH ZERO DEFECTS OBSERVED. BARREL LEAKAGE TEST - 300 SYRINGES TESTED. 27 SYRINGES FOUND WITH LEAKAGE ISSUES DUE TO BARREL DAMAGE. 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. THE ROOT CAUSE FOR THE LEAKAGE CONFIRMED IS DUE TO DAMAGED SYRINGE/BARREL DURING THE ASSEMBLY PROCESS. IT IS POSSIBLE THAT SEVERAL SYRINGES WERE DAMAGED DURING THE HIGH SPEED ASSEMBLY PROCESS. IT IS ALSO POSSIBLE THAT THIS FAILURE WAS ISOLATED DURING THE BATCH RUN IMPACTING ONLY FEW SECONDS OF THE PRODUCTION. NO CORRECTIVE ACTIONS RECOMMENDED BASED ON THE LOW DEFECTIVE RATE IDENTIFIED AS OF TODAY. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.
CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER. DEVICE SINGLE USE?: NO. DEVICE RETURNED TO MANUFACTURER: YES.
IT WAS REPORTED THAT THE BD LUER LOK¿ SYRINGES WITH NEEDLES WERE LEAKING WHEN FILLED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
IT WAS REPORTED THAT THE BD LUER LOK¿ SYRINGES WITH NEEDLES WERE LEAKING WHEN FILLED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD LUER LOK¿ SYRINGES WITH NEEDLES WERE LEAKING WHEN FILLED. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 551345 | BD LUER LOK¿ SYRINGE WITH NEEDLE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 8010876 | 30382903095729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |