MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for NEEDLE 30G X 1/2" 30MG/ML manufactured by Unk.
[185189298]
Spontaneous call - mom called said the needle pack was just air then the other needle was broken and she requested a second pack be sent. No further info provided. No info provided if pt missed dose. No adverse event reported. Not known if pt has defective product on hand. No lot or exp dates provided. There are no notes in pt profile specifying which needle. Therefore both needles on profile have been selected for this report. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093922 |
| MDR Report Key | 9877807 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-10 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEEDLE 30G X 1/2" 30MG/ML |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE |
| Product Code | FMI |
| Date Received | 2020-03-24 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | NEEDLE 30G X 1/2" 30MG/ML |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE |
| Product Code | FMI |
| Date Received | 2020-03-24 |
| Device Availability | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Brand Name | 300MG/ML |
| Product Code | --- |
| Date Received | 2020-03-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |