BD SYRINGE 20ML LUER LOK (PRECISE)
Report
- Report Number
- 8041187-2021-01069
- Event Type
- Malfunction
- Date Received
- December 22, 2021
- Date of Event
- November 25, 2021
- Report Date
- January 6, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMF
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/13/2021. H.6. INVESTIGATION: TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTOS, THE TEAM OBSERVED A SOLID PIECE OF FOREIGN MATTER INSIDE THE SYRINGE PRODUCT. UPON INSPECTION OF THE RECEIVED SAMPLE, THE TEAM OBSERVED A PIECE OF BROKEN PLUNGER INSIDE THE BARREL. 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. THIS NONCONFORMANCE COULD HAVE OCCURRED AT THE ASSEMBLY MACHINE. WHEN THERE IS A MOLDED PLUNGER JAMMED AT THE ASSEMBLY DIAL, THE MACHINE DIALS ARE UNABLE TO TURN AND THE PRODUCTION TECHNICIAN WILL REMOVE THE TOP THUMB-PRESS OF THE MOLDED PLUNGER WITH A CUTTER, THEN SLOWLY ADJUST THE DIALS UNTIL THE JAMMED PLUNGER IS FREE FROM THE TIGHT SPOT. DURING THE CUTTING, THE BROKEN PIECE COULD HAVE FLOWN OFF AND DROP INSIDE THE BARREL.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THE BD SYRINGE 20ML LUER LOK (PRECISE) HAD FOREIGN MATTER IN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT FOREIGN BODY WAS FOUND INSIDE THE SYRINGE.
IT WAS REPORTED THE THE BD SYRINGE 20ML LUER LOK (PRECISE) HAD FOREIGN MATTER IN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT FOREIGN BODY WAS FOUND INSIDE THE SYRINGE.
IT WAS REPORTED THE BD SYRINGE 20ML LUER LOK (PRECISE) HAD FOREIGN MATTER IN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT FOREIGN BODY WAS FOUND INSIDE THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1959598 | BD SYRINGE 20ML LUER LOK (PRECISE) | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL (SINGAPORE) | 0359194 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |