BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE
Report
- Report Number
- 8041187-2021-01097
- Event Type
- Malfunction
- Date Received
- January 6, 2022
- Date of Event
- December 8, 2021
- Report Date
- January 28, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- UDI-DI
- 00382903057801
- PMA / PMN Number
- K010188
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PMA / 510(K) #: THERE IS TWO 510(K) NUMBERS FOR THIS DEVICE AS IT IS MANUFACTURED AS A NEEDLE AND SYRINGE. K941562 (SYRINGE); K161170 (NEEDLE). THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMI/FMF. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
PMA / 510(K) #: THERE IS TWO 510(K) NUMBERS FOR THIS DEVICE AS IT IS MANUFACTURED AS A NEEDLE AND SYRINGE. K941562 (SYRINGE); K161170 (NEEDLE). THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMI/FMF. COMMON DEVICE NAME: HYPODERMIC SINGLE LUMEN NEEDLE; PISTON SYRINGE. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL, YES. D10: RETURNED TO MANUFACTURER ON: 2022-01-19. H6: INVESTIGATION SUMMARY: ONE PHOTO AND NINE SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM WAS UNABLE TO OBSERVE EXCESSIVE LUBRICANT ON THE 1 ML PLUNGER AS THE PHOTO PROVIDED IS NOT CLEAR. THE SAMPLES, EIGHT WITH OPEN PACKAGING AND ONE REPRESENTATIVE, WERE SUBJECTED TO VISUAL INSPECTION TO CHECK FOR EXCESSIVE LUBRICANT ON THE 1 ML PLUNGER. EXCESSIVE LUBRICANT WAS OBSERVED ON THE PLUNGER FOR ALL NINE SAMPLES. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PACKAGING LINE WAS REVIEWED AND THERE IS NO LUBRICANT (SILICONE) USED AT THE LINE. THE 1 ML SYRINGE PART IS FROM BD CANAAN, AND THEIR QUALITY TEAM HAS PERFORMED A SUPPLEMENTAL INVESTIGATION. THE SAMPLES WERE VISUALLY EVALUATED, AND EACH SAMPLE WAS OBSERVED TO HAVE EXCESSIVE SILICONE BOTH IN THE FLUID PATH AND OUTSIDE OF THE FLUID PATH. THE SILICONE WAS SEEN POOLED BEHIND THE STOPPER AND COATING THE PLUNGER ROD AND THE BARREL EXTERIOR WAS SLIPPERY TO THE TOUCH. AFTER A THOROUGH INVESTIGATION, THE POTENTIAL ROOT CAUSES FOR THIS DEFECT WERE DETERMINED TO BE IMPROPER POSITIONING OF THE SILICONE GUN LEADING TO OVERSPRAY ON THE BARREL FLANGES AND THE MACHINE DIAL, EXCESSIVE SILICONE PRESENCE DUE TO THE MISUSE OF THE SILICONE GUN PURGE FUNCTION, INADEQUATE CAPTURE AND CONFLICTION IN INSPECTION PROCEDURES FOR SILICONE OUTSIDE OF THE FLUID PATH, AND IMPROPER ADJUSTMENT REQUIREMENTS FOR THE SILICONE PURGE FUNCTION. CORRECTIVE ACTIONS HAVE BEEN AND WILL BE TAKEN INCLUDING THAT THE SILICONE GUN HAS BEEN PINNED DOWN AT THE OPTIMAL LOCATION TO PREVENT SILICONE OVERSPRAY FROM OCCURRING, THE SILICONE PURGE FUNCTION WILL NO LONGER BE ACCESSIBLE TO ANY OPERATORS ON THE MACHINE AND ELECTRONIC CONTROLS WILL BE PUT IN PLACE TO ONLY ALLOW AUTHORIZED ENGINEERS AND TECHNICIANS ACCESS TO THE PURGE FUNCTION, THE PROGRAM WILL BE UPDATED TO NOT ALLOW THE MACHINE TO RUN WHILE THE SILICONE GUN IS PURGING, THE INSPECTION PROCEDURES AND INTERNAL GUIDEBOOKS WILL BE UPDATED TO ADEQUATELY CAPTURE THIS DEFECT, AND THE ADJUSTMENT PROCEDURE FOR THE SILICONE GUN PURGE FUNCTION WILL BE UPDATED TO PROPERLY QUALIFY THE PRODUCT AND CLEAN THE IMPACTED MACHINE AREAS POST PURGE. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.
IT WAS REPORTED WHEN USING THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE, THE DEVICE EXPERIENCED FOREIGN MATTER WITH THE FLUID PATH. THIS EVENT OCCURRED 9 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: EXCESSIVE PLUNGER LUBRICANT.
IT WAS REPORTED WHEN USING THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE, THE DEVICE EXPERIENCED FOREIGN MATTER WITH THE FLUID PATH. THIS EVENT OCCURRED 9 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: EXCESSIVE PLUNGER LUBRICANT.
IT WAS REPORTED WHEN USING THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE, THE DEVICE EXPERIENCED FOREIGN MATTER WITH THE FLUID PATH. THIS EVENT OCCURRED 9 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: EXCESSIVE PLUNGER LUBRICANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 52179 | BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE | SEE H.10. | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | 1204100 | 00382903057801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |