MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2019-05-03 for MYELOGRAM DRUG FREE TRAY 22 G 4324ADF manufactured by Carefusion, Inc.
[143950167]
Pr (b)(4). Initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4). Device evaluated by mfr: photo provided but not yet evaluated.
Patient Sequence No: 1, Text Type: N, H10
[143950168]
Patient (b)(6). Arrived in the radiology department at 1250pm. Patient was on the table and ready to start at 100pm. Radiologist began the procedure at 100pm. Hub broke with needle in its entirety in the patient at 130pm. Radiologist made small incision and was able to retrieve the needle at 215pm patient had 3 stiches and was sent to amsu. Dr. (b)(6) called dr. (b)(6) and notified him of the incident and informed him that the procedure can be done at a different time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2019-00025 |
| MDR Report Key | 8577406 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2019-05-03 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-04-16 |
| Date Mfgr Received | 2019-05-31 |
| Date Added to Maude | 2019-05-03 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 400 EAST FOSTER RD |
| Manufacturer City | MANNFORD OK 74044 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 74044 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYELOGRAM DRUG FREE TRAY 22 G |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2019-05-03 |
| Catalog Number | 4324ADF |
| Lot Number | 718010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 400 EAST FOSTER RD MANNFORD OK 74044 US 74044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-03 |