FDA Adverse Event
Malfunction
Summary report: N
BD SAFETYGLIDE
MDR report key: 19944725
·
Received August 8, 2024
Report
- Report Number
- 1213809-2024-00523
- Event Type
- Malfunction
- Date Received
- August 8, 2024
- Date of Event
- September 21, 2022
- Report Date
- August 26, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMI
- PMA / PMN Number
- K951254
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
Additional Manufacturer Narrative · 0
(B)(4) - SUPPLEMENTAL MDR - NEEDLE CLOGGED/BLOCKED. AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.
Description of Event or Problem · 0
MATERIAL #:305916 BATCH#:2024137, 2024138, 2024137, REGN2119. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ISSUE - CLOGGED NEEDLES. ITEM - 305916. LOT -2024137, 2024138, 2024137, REGN2119.
Description of Event or Problem · 0
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1675107 | BD SAFETYGLIDE | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON MEDICAL SYSTEMS | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |