FDA Adverse Event
Injury
Summary report: N
DOUBLE LUMEN OVUM ASPIRATION NEEDLE
MDR report key: 4235949
·
Received October 30, 2014
Report
- Report Number
- 9680654-2014-00025
- Event Type
- Injury
- Date Received
- October 30, 2014
- Report Date
- October 28, 2014
- Manufacturer
- WILLIAM COOK AUSTRALIA
- Product Code
- MQE
- PMA / PMN Number
- K983593
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UDI#: (B)(4). INVESTIGATION STILL IN PROGRESS.
Description of Event or Problem · 1
IT WAS REPORTED THAT EXCESSIVE BLEEDING OCCURRED IN MULTIPLE CASES (EXACT NUMBER STILL TO BE DETERMINED) WITH THE USE OF NEEDLES FROM THIS PARTICULAR BATCH, ALLEGEDLY DUE TO THE NEEDLES BEING TOO SHARP. NO SPECIFIC EVENT DATE OR INFORMATION WAS PROVIDED FOR EACH CASE. THE PT WAS EITHER CAUTERIZED, SUTURED, OR EXTENDED PRESSURE WAS APPLIED TO STOP THE BLEEDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 694661 | DOUBLE LUMEN OVUM ASPIRATION NEEDLE | NONE | MQE | WILLIAM COOK AUSTRALIA | A932535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NOT PRO | Required Intervention |