MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-25 for SAFETY NEEDLE UNK NS manufactured by Covidien.
[78510683]
An investigation is currently under way. Upon completion the results will be forwarded. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[78510684]
The customer reports local anesthetic leaks out from the joint of the syringe luer slip and magellan safety needle during injection. Also, when taking iv blood sample for blood gas analysis, she has noted bubbles entering the syringe from seal of luer slip and magellan needle.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017768-2017-05094 |
| MDR Report Key | 6666075 |
| Date Received | 2017-06-25 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-18 |
| Date Added to Maude | 2017-06-25 |
| 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 | EDWARD ALMIEDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2010 E INTERNATIONAL SPEEDWAY |
| Manufacturer City | DELAND FL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SAFETY NEEDLE |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN, REPROCESSED |
| Product Code | NKK |
| Date Received | 2017-06-25 |
| Model Number | UNK NS |
| Catalog Number | UNK NS |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2010 E INTERNATIONAL SPEEDWAY DELAND FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-25 |