MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,company representative, report with the FDA on 2013-06-14 for INJECTION NEEDLE MCL55-1 240MM BAYONET [MXI/XOM] manufactured by Medtronic Xomed, Inc..
[3541006]
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.
Patient Sequence No: 1, Text Type: D, B5
[10838899]
This device is used for therapeutic purposes. (b)(4). Product will not be returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[10942066]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[103689612]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000027-2013-00005 |
| MDR Report Key | 3169812 |
| Report Source | 06,07,COMPANY REPRESENTATIVE, |
| Date Received | 2013-06-14 |
| Date of Report | 2013-05-21 |
| Date of Event | 2013-05-17 |
| Date Mfgr Received | 2013-08-07 |
| Date Added to Maude | 2013-09-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 43328 |
| Manufacturer G1 | MEDTRONIC XOMED, INC |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE N |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INJECTION NEEDLE MCL55-1 240MM BAYONET [MXI/XOM] |
| Generic Name | SET, LARYNGEAL INJECTION |
| Product Code | KAA |
| Date Received | 2013-06-14 |
| Model Number | MCL55-1 |
| Catalog Number | MCL55-1 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-06-14 |