FDA Adverse Event
Malfunction
Summary report: N
25GA X 1 1/2 INCH BD PRECISIONGLIDE¿ NEEDLE
MDR report key: 6745876
·
Received July 26, 2017
Report
- Report Number
- 1911916-2017-00112
- Event Type
- Malfunction
- Date Received
- July 26, 2017
- Date of Event
- February 27, 2017
- Report Date
- July 24, 2017
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMI
- PMA / PMN Number
- K021475
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: ONE UNIT WAS RECEIVED FOR EVALUATION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND CONFIRMED AN EPOXY SPLATTER ON THE SHAFT OF THE NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORDS FOR REPORTED LOT 6053531 REVEALED NO IRREGULARITIES THAT WOULD CONTRIBUTE TO THE REPORTED ISSUE. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE BASED ON THE PROVIDED SAMPLE. THE ENGINEER CONCLUDES THE EPOXY WAS LIKELY INTRODUCED DURING THE ASSEMBLY PROCESS. ACTION HAS BEEN TAKEN TO ADDRESS OCCURRENCES OF THIS NATURE. UDI#: (B)(4).
Description of Event or Problem · 1
THE CUSTOMER REPORTED SOMETHING WAS ON THE 25GA X 1 1/2 INCH BD PRECISION-GLIDE¿ NEEDLE. IT APPEARED TO BE AN IMPERFECTION IN THE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 523660 | 25GA X 1 1/2 INCH BD PRECISIONGLIDE¿ NEEDLE | HYPODERMIC NEEDLE | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 6053531 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |