BD ECLIPSE¿ NEEDLE W/ DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 8041187-2022-00049
- Event Type
- Malfunction
- Date Received
- January 28, 2022
- Date of Event
- January 10, 2022
- Report Date
- April 4, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- UDI-DI
- 30382903057802
- PMA / PMN Number
- K161170
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMF. COMMON DEVICE NAME: PISTON SYRINGE. PMA / 510(K)#: K941562. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FMF. COMMON DEVICE NAME: PISTON SYRINGE. PMA / 510(K)#: K941562. 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: 14-MAR-2022. H6: INVESTIGATION SUMMARY TWO SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. AS THE SAMPLE IS MANUFACTURED AT BD CANAAN, FUNCTIONAL TESTING WAS NOT PERFORMED BY TUAS AS TO NOT DESTROY THE 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 QUALITY TEAM AT BD CANAAN HAS PERFORMED A SUPPLEMENTAL INVESTIGATION ON THE RETURNED SAMPLES. IN THE PHOTO, A 1 ML LUER-LOK SYRINGE CAN BE SEEN WITH AN ECLIPSE NEEDLE ATTACHED. THE PLUNGER ROD IS DRAWN OUT TO THE 0.6 ¿ 0.7 ML AREA OF THE SYRINGE. THE REPORTED DEFECT COULD NOT BE OBSERVED IN THE RETURNED PHOTO. THE PHYSICAL SAMPLES WERE RECEIVED IN AN UNSEALED BLISTER-PACKS. UPON EXERCISING BOTH PLUNGER RODS, THEY WERE SMOOTH TO DRAW, AND THE REPORTED DEFECT COULD NOT BE IDENTIFIED OR CONFIRMED IN THE SAMPLES RECEIVED. AS THE DEFECT COULD NOT BE CONFIRMED, A ROOT CAUSE COULD NOT BE DETERMINED. H3 OTHER TEXT : SEE H10.
H.6. INVESTIGATION: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. 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. A DEVICE HISTORY REVIEW WAS ALSO PERFORMED BY BD CANAAN, WHERE THE SYRINGE PART WAS MANUFACTURED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND FOR THE REPORTED LOT NUMBER. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE W/ DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE HAD PLUNGERS THAT WERE DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS HARD TO PUSH.
IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE W/ DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE HAD PLUNGERS THAT WERE DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS HARD TO PUSH.
IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE W/ DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE HAD PLUNGERS THAT WERE DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS HARD TO PUSH.
IT WAS REPORTED THAT 2 BD ECLIPSE¿ NEEDLE W/ DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE HAD PLUNGERS THAT WERE DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLUNGER IS HARD TO PUSH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1736150 | BD ECLIPSE¿ NEEDLE W/ DETACHABLE 1 ML BD LUER-LOK¿ SYRINGE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | 305780 | 1204100 | 30382903057802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |