MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-06-30 for PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT 4698P-2 manufactured by Smiths Medical Asd, Inc..
[484394]
User alleges blood leakage past plunger that resulted in blood exposure. No treatment.
Patient Sequence No: 1, Text Type: D, B5
[7787784]
The user facility did not save any of the samples that they had a problem with. Our investigation was based on samples evaluated from the same lot that the user facility reported on. The samples were from smiths medical inventory. A review of the manufacturing records showed no problem during manufacturer. Samples, of the same lot, were tested for leakage past plunger and all samples tested did not leak. A review of our complaints database reveals no other reports on this device lot number. This report is unconfirmed and, due to no other reports on the lot, isolated.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2006-00041 |
| MDR Report Key | 734340 |
| Report Source | 05,06 |
| Date Received | 2006-06-30 |
| Date of Event | 2006-06-01 |
| Date Mfgr Received | 2006-06-07 |
| Device Manufacturer Date | 2006-05-01 |
| Date Added to Maude | 2006-07-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY MATSON |
| Manufacturer Street | * |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| Manufacturer Street | * |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03431 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT |
| Generic Name | TRAY, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2006-06-30 |
| Model Number | NA |
| Catalog Number | 4698P-2 |
| Lot Number | 1016650 |
| ID Number | * |
| Device Expiration Date | 2009-04-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 722211 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DRIVE KEENE NH 03431 US |
| Baseline Brand Name | TRAY, BLOOD COLLECTION |
| Baseline Generic Name | TRAY, BLOOD COLLECTION |
| Baseline Model No | NA |
| Baseline Catalog No | 4698P-2 |
| Baseline ID | CP495 |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K911638 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-30 |