MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2015-06-08 for HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE 4658305 manufactured by Smiths Medical Inc..
[15968495]
A report was rec'd that state during an injection, the needle became detached from the syringe. No needle-stick took place. There was no pt or clinician injury reported.
Patient Sequence No: 1, Text Type: D, B5
[16353257]
Manufacturer completed the entire form. Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00404 |
| MDR Report Key | 4838147 |
| Report Source | 01,08 |
| Date Received | 2015-06-08 |
| Date of Report | 2015-06-08 |
| Report Date | 2015-06-08 |
| Date Reported to FDA | 2015-06-08 |
| Date Mfgr Received | 2015-05-18 |
| Device Manufacturer Date | 2014-11-18 |
| Date Added to Maude | 2015-06-23 |
| 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 | MICHELE SELIGA |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287604 |
| Manufacturer G1 | SMITHS MEDICAL, INC. |
| Manufacturer Street | 10 BOWMAN DR |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HYPODERMIC NEEDLE-PRO NEEDLE WITH PROTECTION DEVICE |
| Generic Name | HYPODERMIC NEEDLE |
| Product Code | FMJ |
| Date Received | 2015-06-08 |
| Model Number | NA |
| Catalog Number | 4658305 |
| Lot Number | 2736438 |
| ID Number | NA |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INC. |
| Manufacturer Address | KEENE NH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-08 |