BD LUER-LOK¿ TIP SYRINGE
Report
- Report Number
- 1213809-2022-00692
- Event Type
- Malfunction
- Date Received
- October 11, 2022
- Date of Event
- September 15, 2022
- Report Date
- October 17, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903010295
- PMA / PMN Number
- K980987
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1111285; MEDICAL DEVICE EXPIRATION DATE: 31-MAR-2026; DEVICE MANUFACTURE DATE: 21-APR-2021; MEDICAL DEVICE LOT #: 1152292; MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2026; DEVICE MANUFACTURE DATE: 01-JUN-2021; MEDICAL DEVICE LOT #: 1111296; MEDICAL DEVICE EXPIRATION DATE: 30-APR-2026; DEVICE MANUFACTURE DATE: 21-APR-2021; MEDICAL DEVICE LOT #: 1239987; MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026; DEVICE MANUFACTURE DATE: 27-AUG-2021; MEDICAL DEVICE LOT #: 1270083; MEDICAL DEVICE EXPIRATION DATE: 31-AUG-2026; DEVICE MANUFACTURE DATE: 27-SEP-2021. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY ELEVEN SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LIQUID SUBSTANCE WAS STRINGING FROM THE ROOF OF THE BARREL TO THE STOPPER WAS OBSERVED. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS RESULT SHOWED THAT THE FOREIGN MATTER WAS SILICONE LUBRICANT. SILICONE IS A VITAL COMPONENT OF THE MANUFACTURING PROCESS, AND ALLOWS FOR THE PISTON TO GLIDE INSIDE OF THE SYRINGE, IT IS A SAFE AND COMMONLY USED COMPONENT IN THE MEDICAL DEVICE INDUSTRY. POTENTIAL ROOT CAUSE FOR THE EXCESS SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS MOST LIKELY A DEFICIENT SILICONE GUN OR IMPROPER ADJUSTMENT TO THE SILICONE SYSTEM LED TO THE OBSERVED CONDITION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED THAT AT LEAST ONE BD LUER-LOK¿ TIP SYRINGE EACH FROM LOTS 1111285, 1152292, 1111296, 1239987, AND 1270083 HAD OILY RESIDUE ON THEIR PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "THE SYRINGES FEEL GREASY AND AN OILY SUBSTANCE IS VISIBLE ON TOP OF THE PLUNGER RUBBER. THIS IS IN CONTRAST TO THE NORMAL OIL-LIKE LIQUID THIS IS ON TOP OF THE PLUNGER. WHEN SLOWLY MOVING THE PLUNGER DOWN, THIS SUBSTANCE ALSO DRAWS 'THREADS' BETWEEN THE RUBBER AND THE INSIDE OF THE TOP OF THE SYRINGE... ALSO, WHEN MOVING THE PLUNGER INSIDE THE SYRINGE, A 'GREASY RELEASE SOUND' CAN BE HEARD (SORRY, I'M NOT SURE HOW TO DESCRIBE IT)."
IT WAS REPORTED THAT AT LEAST ONE BD LUER-LOK¿ TIP SYRINGE EACH FROM LOTS 1111285, 1152292, 1111296, 1239987, AND 1270083 HAD OILY RESIDUE ON THEIR PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH: "THE SYRINGES FEEL GREASY AND AN OILY SUBSTANCE IS VISIBLE ON TOP OF THE PLUNGER RUBBER. THIS IS IN CONTRAST TO THE NORMAL OIL-LIKE LIQUID THIS IS ON TOP OF THE PLUNGER. WHEN SLOWLY MOVING THE PLUNGER DOWN, THIS SUBSTANCE ALSO DRAWS 'THREADS' BETWEEN THE RUBBER AND THE INSIDE OF THE TOP OF THE SYRINGE... ALSO, WHEN MOVING THE PLUNGER INSIDE THE SYRINGE, A 'GREASY RELEASE SOUND' CAN BE HEARD (SORRY, I'M NOT SURE HOW TO DESCRIBE IT)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 245986 | BD LUER-LOK¿ TIP SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | SEE H10 | 00382903010295 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |