MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-09 for NEURO TRAY WITH SYRINGE SPEC0070 manufactured by Medline Industries, Inc..
[126654525]
Md was beginning the set up of a patient's shoulder injection when she noticed that the syringe used to draw up lidocaine was cracked. The same md had the same thing happen a week prior while setting up another procedure. Another md at a nearby facility also had this happen to her with the same kit. The crack was not identified in this instance and the lidocaine shot across the room. In this event, the reporter of this event has spoken to the vendor and the vendor came to pick up the syringe and to take a look at it last week.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8054665 |
| MDR Report Key | 8054665 |
| Date Received | 2018-11-09 |
| Date of Report | 2018-11-01 |
| Date of Event | 2018-10-24 |
| Report Date | 2018-11-02 |
| Date Reported to FDA | 2018-11-02 |
| Date Reported to Mfgr | 2018-11-09 |
| Date Added to Maude | 2018-11-09 |
| 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 |
| 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 | 3 |
| Brand Name | NEURO TRAY WITH SYRINGE |
| Generic Name | NEUROLOGICAL TRAY |
| Product Code | OJG |
| Date Received | 2018-11-09 |
| Returned To Mfg | 2018-10-18 |
| Model Number | SPEC0070 |
| Catalog Number | SPEC0070 |
| Lot Number | 2018072450 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-09 |