MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-22 for HYPODERMIC NEEDLE-PRO DEVICE 4292 manufactured by Smiths Medical Inc.
[5824714]
A report was received that stated during an injection, the needle became detached from the syringe. No needle-stick took place. Ther was no patient or clinician injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13265281]
Device evaluation: one case of hypodermic needles of the complaint lot was returned for evaluation. (b)(4) random samples were examined. Visual inspection observed no non-conformities with the device. During functional testing, the cannula was tightened to the device per direction found in the instruction for use. Testing found no leakages or detachment of the cannula. The returned device was found to operate as intended. No evidence was found to suggest the reported event was caused from intrinsic product fault.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2015-00271 |
| MDR Report Key | 4734805 |
| Report Source | 06 |
| Date Received | 2015-04-22 |
| Date of Report | 2015-04-22 |
| Report Date | 2015-04-22 |
| Date Reported to FDA | 2015-04-22 |
| Date Mfgr Received | 2015-04-03 |
| Device Manufacturer Date | 2014-09-26 |
| Date Added to Maude | 2015-06-08 |
| 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 DEVICE |
| Generic Name | FMJ-HYPODERMIC NEEDLE |
| Product Code | FMJ |
| Date Received | 2015-04-22 |
| Returned To Mfg | 2015-04-13 |
| Model Number | NA |
| Catalog Number | 4292 |
| Lot Number | 2771443 |
| ID Number | NA |
| Device Expiration Date | 2019-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL INC |
| Manufacturer Address | KEENE NH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-22 |