FDA Adverse Event
Malfunction
Summary report: N
BD¿ LUER-LOK SYRINGE 60 ML
MDR report key: 6730715
·
Received July 20, 2017
Report
- Report Number
- 1911916-2017-00080
- Event Type
- Malfunction
- Date Received
- July 20, 2017
- Date of Event
- June 20, 2017
- Report Date
- December 1, 2017
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- PMA / PMN Number
- K110771
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
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).
Additional Manufacturer Narrative · 1
RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7023514. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PIECE OF DIRT WAS FOUND IN A BD¿ LUER-LOK SYRINGE 60 ML BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 508751 | BD¿ LUER-LOK SYRINGE 60 ML | HYPODERMIC SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 7023514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |