BD ECLIPSE¿ NEEDLE
Report
- Report Number
- 8041187-2022-00047
- Event Type
- Malfunction
- Date Received
- January 27, 2022
- Date of Event
- January 11, 2022
- Report Date
- March 16, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- UDI-DI
- 30382903057826
- PMA / PMN Number
- SEE H.10.
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (SYRINGE). PMA / 510(K)#: K161170 (NEEDLE). 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: 2022-03-03. H6: INVESTIGATION SUMMARY: ONE PHOTO AND ONE SYRINGE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, LEAKAGE AT THE CONNECTION BETWEEN THE SYRINGE TIP AND AN UNKNOWN DEVICE. THE RETURNED SYRINGE WAS ATTACHED TO AN UNKNOWN MEDICAL DEVICE. SIGNS OF LIQUID CAN BE SEEN INSIDE THE SYRINGE BARREL AND INSIDE THE COLLAR THREAD. THE SYRINGE WAS SUBJECTED TO VISUAL INSPECTION TO CHECK FOR DAMAGE SYRINGE TIP AND COLLAR THREAD. NO DAMAGE WAS OBSERVED ON THE SYRINGE TIP AND COLLAR THREAD WERE OBSERVED. AFTER DECONTAMINATION, THE SYRINGE SAMPLE WAS SUBJECTED TO LEAK TESTING AND PASSED. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.
THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K980987 (SYRINGE). PMA / 510(K)#: K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, LEAKAGE WAS OBSERVED AT THE CONNECTION BETWEEN THE SYRINGE TIP AND AN UNKNOWN DEVICE. 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. AS THE ACTUAL SAMPLE WAS NOT RETURNED TO FURTHER EXAMINE THE SYRINGE TIP, THE ROOT CAUSE COULD NOT BE DETERMINED.
IT WAS REPORTED BD ECLIPSE¿ NEEDLE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE"
IT WAS REPORTED BD ECLIPSE¿ NEEDLE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE."
IT WAS REPORTED BD ECLIPSE¿ NEEDLE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE"
IT WAS REPORTED BD ECLIPSE¿ NEEDLE HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 592444 | BD ECLIPSE¿ NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | 305782 | 1204165 | 30382903057826 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |