MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-09 for NEEDLE manufactured by Unk.
[105169444]
Patient complained of many needles not working. No matter how hard he presses on the button to release the dose, insulin does not come through the needle. Verified with patients that both caps were removed and needle was attached to pen properly. Patient stated that some needles in the box worked, while others did not. Symptoms: defective needle. Suspect drug: #1 dosing: use to inject insulin 4 times per day. Diagnosis for use: diabetes mellitus.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076399 |
| MDR Report Key | 7411625 |
| Date Received | 2018-04-09 |
| Date of Report | 2018-04-06 |
| Date of Event | 2018-03-28 |
| Date Added to Maude | 2018-04-10 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEEDLE |
| Generic Name | NEEDLE |
| Product Code | MQX |
| Date Received | 2018-04-09 |
| Lot Number | 458512P |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-04-09 |