MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-03-31 for HYPOEDERMIC NEEDLE-PRO W/NEEDLE PROTECTION DEVICE G1741 manufactured by Smiths Medical Md, Inc..
[5603624]
A report was rec'd that stated prior to injection clinician was unable to correctly attach the needle to the syringe. Clinician proceeded to administer the medication to the pt while holding parts together, which resulted in a leak as the needle was not fully attached. No needle-stick took place. There was no pt or clinician injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13207751]
Customer has not yet returned the device to the mfr for eval. When and if the device becomes available and is returned and evaluated, the mfr will file a f/u report detailing the results of the eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00202 |
| MDR Report Key | 4668947 |
| Report Source | 08 |
| Date Received | 2015-03-31 |
| Date of Report | 2015-03-21 |
| Date of Event | 2015-03-11 |
| Date Facility Aware | 2015-03-11 |
| Report Date | 2015-03-31 |
| Date Reported to FDA | 2015-03-31 |
| Date Mfgr Received | 2015-03-13 |
| Date Added to Maude | 2015-05-15 |
| 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 | PETE HIRTE |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6516287384 |
| Manufacturer G1 | SMITHS MEDICAL MD, 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 | HYPOEDERMIC NEEDLE-PRO W/NEEDLE PROTECTION DEVICE |
| Generic Name | FMJ - NEEDLE, HYPODERMIC |
| Product Code | FMJ |
| Date Received | 2015-03-31 |
| Catalog Number | G1741 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL MD, INC. |
| Manufacturer Address | KEENE NH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-31 |