MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2013-08-29 for INJECTION NEEDLE MCL55U 250MM MALLEABLE manufactured by Medtronic Xomed Instrumentation S.a.s..
[17344569]
Twenty two devices (part#: mcl55u) were returned to mxi svc and repair.
Patient Sequence No: 1, Text Type: D, B5
[17552151]
Ml55u (qty 21 - lot:unk) - mfg date:unk. (b)(6). Evaluation of the device indicated that the needles were broken and/or bent. Note: this mdr is being filed as a result of an internal review of complaints from medtronic's mxi facility in (b)(4). This review was conducted to resolve several issues discovered i the mxi complaint handling process. Issues resolved include the misclassification of devices returned for repair, as well as gaps in reporting. Mxi capa (b)(4) was opened to address these issues. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2013-00082 |
| MDR Report Key | 3337559 |
| Report Source | 01,07 |
| Date Received | 2013-08-29 |
| Date of Report | 2010-02-10 |
| Date of Event | 2010-02-10 |
| Date Mfgr Received | 2010-02-10 |
| Date Added to Maude | 2013-11-29 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JONATHAN SCHLECH |
| Manufacturer Street | 6743 SOUTHPOINT DR. |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328355 |
| Manufacturer G1 | MEDTRONIC XOMED INSTRUMENTATION S.A.S. |
| Manufacturer Street | LE PAVILLON |
| Manufacturer City | SAINT AUBIN LE MONIAL 03160 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 03160 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INJECTION NEEDLE MCL55U 250MM MALLEABLE |
| Product Code | GDM |
| Date Received | 2013-08-29 |
| Returned To Mfg | 2010-02-10 |
| Model Number | MCL55U |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INSTRUMENTATION S.A.S. |
| Manufacturer Address | LE PAVILLON SAINT AUBIN LE MONIAL 03160 FR 03160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-29 |