MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-12 for HYPODERMIC NEEDLE-PRO WITH NEEDLE PROTECTION DEVICE UNK manufactured by Smiths Medical, Inc..
[5936769]
A report was received that stated during an injection, the needle became detached from the syringe and the solution leaked out. No needle-stick or drug exposure took place. There was no pt or clinician injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13351143]
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 | 2183502-2015-00416 |
| MDR Report Key | 4848274 |
| Report Source | 08 |
| Date Received | 2015-06-12 |
| Date of Report | 2015-06-12 |
| Date of Event | 2015-05-27 |
| Report Date | 2015-05-08 |
| Date Reported to FDA | 2015-06-12 |
| Date Mfgr Received | 2015-05-27 |
| Date Added to Maude | 2015-06-25 |
| 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 | 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 DRIVE |
| 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 WITH NEEDLE PROTECTION DEVICE |
| Generic Name | FMJ-NEEDLE, HYPODERMIC |
| Product Code | FMJ |
| Date Received | 2015-06-12 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| 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 | 2015-06-12 |