MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-06 for 22 G X 1.5 INCH NEEDLE DYNJ4419A * manufactured by Medline Industries Inc.
[21117883]
This needle came in the custom pack and did not have a hole in the end of it. Another lumbar tray opened. No patient harm. ======================manufacturer response for 22 g x 1. 5 inch needle, (brand not provided) (per site reporter). ======================i emailed our rep to inform him of this needle. I am awaiting his response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4894294 |
| MDR Report Key | 4894294 |
| Date Received | 2015-07-06 |
| Date of Report | 2015-07-06 |
| Date of Event | 2015-06-11 |
| Report Date | 2015-07-06 |
| Date Reported to FDA | 2015-07-06 |
| Date Reported to Mfgr | 2015-07-07 |
| Date Added to Maude | 2015-07-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 22 G X 1.5 INCH NEEDLE |
| Generic Name | NEEDLE, TRAY |
| Product Code | LRP |
| Date Received | 2015-07-06 |
| Model Number | DYNJ4419A |
| Catalog Number | * |
| Lot Number | 15EB3253 |
| ID Number | * |
| Device Availability | R |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-06 |