MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-03-28 for INJECTION NEEDLE MCL55-3 240MM BAYONET [MXI/XOM] manufactured by Xomed Microfrance Mfg.
[17158199]
It was reported that a 240mm bayonet injection needle broke. However, analysis of the complaint device confirmed the break resulted in a 3cm device fragment that was not returned by the customer. There was no report of patient impact or injury as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[17365883]
(b)(4). In response to medtronic? S request for device return, the device was returned to medtronic? S international manufacturing site for evaluation purposes. The investigation report findings are detailed as follows: the needle is broken right after the laser weld? The second part was not returned. No manufacturing or material defect was observed. The most probable cause of this breakage is an excessive effort during use or the reprocessing of the instrument. It is very fragile and in the case of a deformation, it is impossible to straighten it without breaking the tube. This device is used for therapeutic purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2014-00021 |
| MDR Report Key | 3709371 |
| Report Source | 01,06,07 |
| Date Received | 2014-03-28 |
| Date of Report | 2014-03-03 |
| Date of Event | 2014-02-26 |
| Date Mfgr Received | 2014-03-03 |
| Device Manufacturer Date | 2013-10-01 |
| Date Added to Maude | 2014-05-28 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JACKLYN HAYMAN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042812769 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| 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 MCL55-3 240MM BAYONET [MXI/XOM] |
| Generic Name | NEEDLE, ASPIRATION AND INJECTION, REUSABLE |
| Product Code | GDM |
| Date Received | 2014-03-28 |
| Returned To Mfg | 2014-03-03 |
| Model Number | MCL55-3 |
| Catalog Number | MCL55-3 |
| Lot Number | 131001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICROFRANCE MFG |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-28 |