MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-17 for 25 G NEEDLE DYNJ06653688 manufactured by Medline.
[75607523]
The surgeon was injecting into the shoulder with the 25 gauge needle when the needle broke in half. The surgeon was able to remove it with a clamp. Medline complaint number: (b)(4). Dates of use: (b)(6) 2017. Diagnosis or reason for use: infection into the shoulder during a surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069866 |
| MDR Report Key | 6577944 |
| Date Received | 2017-05-17 |
| Date of Report | 2017-04-18 |
| Date of Event | 2017-04-18 |
| Date Added to Maude | 2017-05-19 |
| 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 | RISK MANAGER |
| 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 | 25 G NEEDLE |
| Generic Name | NEEDLE |
| Product Code | FSH |
| Date Received | 2017-05-17 |
| Returned To Mfg | 2017-04-11 |
| Model Number | DYNJ06653688 |
| Lot Number | 16FK0624 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | 1170 NORTH POINT BLVD MEDLINE B04 WAUKEGAN IL 60045 US 60045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-05-17 |