MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-02 for SAFE-T-CENTESIS TRAY 6FR X 16CM PIG1260T manufactured by Carefusion, Inc.
[173348056]
Pr (b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[173348057]
Tubing too soft and kinking during procedure. In one case the tubing kinked and the syringe came disconnected from valve, resulting in the dr and patient? Being covered? In pleural fluid. No intervention reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625685-2020-00001 |
| MDR Report Key | 9539295 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-02 |
| Date of Report | 2020-02-05 |
| Date of Event | 2019-12-08 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-01-02 |
| 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 Phone | 8015652341 |
| 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 | SAFE-T-CENTESIS TRAY 6FR X 16CM |
| Generic Name | NEEDLE, CATHETER |
| Product Code | GCB |
| Date Received | 2020-01-02 |
| Catalog Number | PIG1260T |
| Lot Number | 0001324093 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-01-02 |