MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-12-27 for PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT * 4699P-1 manufactured by Smiths Medical Asd, Inc..
[565940]
User alleges she performed a blood draw, when she withdrew the needle from the pt, the needle was warbling and she was stuck with a contaminated needle.
Patient Sequence No: 1, Text Type: D, B5
[7987816]
Evaluations: smiths medical is unable to fully investigate this issue as the sample was not retained for investigation. The user stated that event was due to the needle warbling after the draw. She reported that she had secured the connection per the instructions for use (ifu). The user facility reported that they are a long time user and they could not reproduce the user's event. The user is no longer employed at this facility. In reviewing the ifu the following steps are stated: 3. 5 seat the needle firmly on the needle-pro device with a push and a slight twist. 3. 6 pull sheath straight away from needle. Do not twist sheath as needle may be loosened from the needle-pro device. It is likely this event was due to user device interface.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2006-00100 |
| MDR Report Key | 799176 |
| Report Source | 05,06 |
| Date Received | 2006-12-27 |
| Date of Report | 2006-12-04 |
| Date of Event | 2006-11-01 |
| Date Mfgr Received | 2006-12-04 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2007-01-03 |
| 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 |
| 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 | 75 GJE-TRAY, BLOOD COLLECTION |
| Product Code | GJE |
| Date Received | 2006-12-27 |
| Model Number | * |
| Catalog Number | 4699P-1 |
| Lot Number | 1038840 |
| ID Number | * |
| Device Expiration Date | 2008-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 786694 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US |
| Baseline Brand Name | PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT |
| Baseline Generic Name | TRAY, BLOOD COLLECTION |
| Baseline Model No | NA |
| Baseline Catalog No | 4699P-1 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-12-27 |