MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-08 for MONOJECT 8881135015 manufactured by Cardinal Health, Inc..
[135517411]
A 35 ml enteral feeding syringe was taken from stock to be used to feed a nicu baby. Upon inspection of the syringe, a jagged piece of plastic was seen inside the unused syringe. The 35 ml syringe that was being used had a1 on top of the syringe. The piece of plastic within the syringe appears to be a broken edge of a top of a syringe and has an a8 on top of it. Manufacturer's response per hospital reporter. Covidien stated that this device is now part of cardinal health as of july 28, 2018.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8319762 |
| MDR Report Key | 8319762 |
| Date Received | 2019-02-08 |
| Date of Report | 2019-01-30 |
| Date of Event | 2019-01-28 |
| Report Date | 2019-01-30 |
| Date Reported to FDA | 2019-01-30 |
| Date Reported to Mfgr | 2019-02-08 |
| Date Added to Maude | 2019-02-08 |
| 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 | 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 | 3 |
| Brand Name | MONOJECT |
| Generic Name | ENTERAL SYRINGE, SPECIFIC |
| Product Code | PNR |
| Date Received | 2019-02-08 |
| Model Number | 8881135015 |
| Catalog Number | 8881135015 |
| Lot Number | 631958 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-08 |