MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for PHLEBOTOMY KIT NEEDLE manufactured by Fenwal, Inc..
[44208421]
Patient Sequence No: 1, Text Type: N, H10
[44208422]
A therapeutic phlebotomy kit needle was found with solid particles on the bevel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5624468 |
| MDR Report Key | 5624468 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-25 |
| Date of Event | 2016-04-18 |
| Report Date | 2016-04-25 |
| Date Reported to FDA | 2016-04-25 |
| Date Reported to Mfgr | 2016-04-25 |
| Date Added to Maude | 2016-05-03 |
| 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 | PATIENT |
| 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 | PHLEBOTOMY KIT NEEDLE |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS |
| Product Code | KSR |
| Date Received | 2016-05-03 |
| ID Number | 1FE04R3611 / FM15C24056 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FENWAL, INC. |
| Manufacturer Address | 3 CORPORATE DR. STE. 300 LAKE ZURICH IL 60047 US 60047 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-03 |