MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-22 for PORTEX 4598P-2 193708 manufactured by Smiths Medical Asd, Inc..
[92966128]
No pt harm. Blood spilling outside syringe during collection process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073506 |
| MDR Report Key | 7052215 |
| Date Received | 2017-11-22 |
| Date of Report | 2017-11-17 |
| Date of Event | 2017-11-14 |
| Date Added to Maude | 2017-11-22 |
| 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 | OTHER CAREGIVERS |
| 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 | PORTEX |
| Generic Name | ARTERIAL BLOOD SAMPLING KIT |
| Product Code | CBT |
| Date Received | 2017-11-22 |
| Model Number | 4598P-2 |
| Catalog Number | 193708 |
| Lot Number | 3495049 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | KEENE NH US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-22 |