FDA Adverse Event
Malfunction
Summary report: N
BD ULTRA-FINE INSULIN SYRINGE
MDR report key: 10757900
·
Received October 29, 2020
Report
- Report Number
- 1920898-2020-01496
- Event Type
- Malfunction
- Date Received
- October 29, 2020
- Date of Event
- October 10, 2020
- Report Date
- October 16, 2020
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- PMA / PMN Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BEFORE USE THE BD ULTRA-FINE¿ INSULIN SYRINGE HAD THE HUB SEPARATE FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED ¿WHEN REMOVING THE SHIELD, THE NEEDLE WITH THE SHIED WAS SEPARATED FROM THE BARREL.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1220025 | BD ULTRA-FINE INSULIN SYRINGE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 9337434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |