MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-24 for MONOJECT 1188825112 manufactured by Cardinal Health, Inc..
[184638733]
Attaching a sterile 25gx1. 5inch needle to a 10 ml syringe where i just drew up 5ml each of lidocaine 1% and bupivacaine 0. 5% for injection into a patient. When i attached the sterile needle the clear plastic cap covering the needle fell off onto the counter. I then removed the needle and attached a new sterile needle onto the bd 10 ml luer lock syringe. This is a known issue that was previously reported to supply and the vendor, and we were informed to document occurrences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9871325 |
| MDR Report Key | 9871325 |
| Date Received | 2020-03-24 |
| Date of Report | 2020-02-12 |
| Date of Event | 2020-01-27 |
| Report Date | 2020-02-12 |
| Date Reported to FDA | 2020-02-12 |
| Date Reported to Mfgr | 2020-03-24 |
| Date Added to Maude | 2020-03-24 |
| 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 | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | FMI |
| Date Received | 2020-03-24 |
| Model Number | 1188825112 |
| Catalog Number | 1188825112 |
| Lot Number | 914070 |
| Device Availability | * |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-24 |