BD SAFETYGLIDE¿ NEEDLE
Report
- Report Number
- 1213809-2022-01068
- Event Type
- Malfunction
- Date Received
- November 22, 2022
- Date of Event
- October 31, 2022
- Report Date
- December 30, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- UDI-DI
- 00382903059164
- PMA / PMN Number
- K951254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHARMACIST
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST CALLED TO REPORT THAT HALF OF EVERY BOX THEY HAVE OPENED HAS BEEN CLOGGED. SAME LOT NUMBER FOR ALL 3 BOXES LOT 2024138."
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD SAFETYGLIDE¿ NEEDLES WERE CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACIST CALLED TO REPORT THAT HALF OF EVERY BOX THEY HAVE OPENED HAS BEEN CLOGGED. SAME LOT NUMBER FOR ALL 3 BOXES LOT 2024138."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 248555 | BD SAFETYGLIDE¿ NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL SYSTEMS | 2024138 | 00382903059164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |