FDA Adverse Event
Malfunction
Summary report: N
INJECTION NEEDLE MCL55-1 240MM BAYONET [MXI/XOM]
MDR report key: 3169812
·
Received June 14, 2013
Report
- Report Number
- 6000027-2013-00005
- Event Type
- Malfunction
- Date Received
- June 14, 2013
- Date of Event
- May 17, 2013
- Report Date
- May 21, 2013
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- KAA
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(4). PRODUCT WILL NOT BE RETURNED FOR EVALUATION.
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED WHEN THE SURGEON WAS ATTEMPTING TO PULL THE NEEDLE OUT OF THE STYLETTE AND THE TIP BROKE OFF. THERE WAS RESIDUAL CEMENT IN THERE FROM THE PREVIOUS SURGERY. PATIENT WAS INTUBATED AND SEDATED ON THE TABLE. SURGERY COULD NOT TAKE PLACE AS THEY DIDN¿T HAVE A SPARE NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 270628 | INJECTION NEEDLE MCL55-1 240MM BAYONET [MXI/XOM] | SET, LARYNGEAL INJECTION | KAA | MEDTRONIC XOMED, INC. | MCL55-1 | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Other |