FDA Adverse Event
Malfunction
Summary report: N
BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
MDR report key: 12774753
·
Received November 8, 2021
Report
- Report Number
- 1920898-2021-01165
- Event Type
- Malfunction
- Date Received
- November 8, 2021
- Date of Event
- October 11, 2021
- Report Date
- October 20, 2021
- Manufacturer
- BD MEDICAL - DIABETES CARE
- Product Code
- FMF
- UDI-DI
- 00311917014920
- PMA / PMN Number
- K941657
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED THAT 1 BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NEEDLE SHIELD DIFFICULT TO REMOVE AND THE NEEDLE HUB SEPARATED AND CAME OFF INSIDE OF THE SHIELD. DATE OF EVENT : UNKNOWN. SAMPLES : AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1670310 | BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE | PISTON SYRINGE | FMF | BD MEDICAL - DIABETES CARE | 928852 | 0125318 | 00311917014920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |