FDA Adverse Event
Malfunction
Summary report: N
EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE
MDR report key: 1172848
·
Received September 19, 2008
Report
- Report Number
- 3005099803-2008-04750
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 22, 2008
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- EOQ
- PMA / PMN Number
- K040018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED TO BOSTON SCIENTIFIC THAT DURING THE TRANSBRONCHIAL NEEDLE ASPIRATION PROCEDURE, THE POST CRACKED AND WAS LEAKING, WHERE THE SYRINGE ATTACHES TO THE DEVICE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS AND THE PATIENT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE | EOQ | BOSTON SCIENTIFIC CORPORATION | M00564101 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |