MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-23 for NEURO PACK DYNJ49357A manufactured by Unk.
[101119001]
Pt was in interventional radiology (ir) for a stroke thrombectomy. During the final pass of the device, when the md pulled the stent retriever out, the team noticed a "blue" item within the basket of the device. This "blue" item was not noticed on any prior uses of the device. The device and other catheters on the table were collected and placed into a biohazard bag. The item appears to be blue lint from the towels in the kit. Medline, us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075521 |
| MDR Report Key | 7295987 |
| Date Received | 2018-02-23 |
| Date of Report | 2018-02-22 |
| Date of Event | 2018-02-08 |
| Date Added to Maude | 2018-02-26 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEURO PACK |
| Generic Name | RADIOLOGY DIAGNOSTIC KIT |
| Product Code | OIP |
| Date Received | 2018-02-23 |
| Catalog Number | DYNJ49357A |
| Lot Number | 17TB9215 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Manufacturer Address | UNK UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-23 |