MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2007-09-17 for PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT 4699P-1 manufactured by Smiths Medical Asd, Inc..
[692898]
User alleges several events of when performed a blood draw and, when event to engage the needle, the needle could not click into the needle protection device. No needle sticks reported. User reported that needles bend when go to engage and typically occurs when engaging on a soft surface of the bed.
Patient Sequence No: 1, Text Type: D, B5
[7879584]
Results: our investigation into this event is very limited as the user facility did not retain the needle used in this event. A review of our complaints database show no other reports on this device lot number of the finished good or the needle lot number. A review of the labeling reveals this issue is identified in our instructions for use: a review of the instructions for use reveals: warning that states "bent or damaged needles can result in breakage or damage to the tissue or accidental needle puncture. If the needle is bent or damaged, no attempt should be made to straighten the needle or engage the needle-pro device. The needle-pro device may not properly contain a bent needle and/or the needle could puncture the needle protection device which may result in a needle stick with a contaminated needle. " and a work step "after procedure is completed, press the needle into the sheath using a one-handed technique by gently pressing the sheath against a flat surface. " no corrective action has been assigned as this event is likely due to user error. This report has been logged for trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2007-00110 |
| MDR Report Key | 914202 |
| Report Source | 07 |
| Date Received | 2007-09-17 |
| Date of Report | 2007-08-20 |
| Date Mfgr Received | 2007-08-20 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2007-11-01 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY MATSON |
| Manufacturer City | KEENE NH 03431 |
| Manufacturer Country | US |
| Manufacturer Postal | 03431 |
| Manufacturer Phone | 6033523812 |
| Manufacturer G1 | SMITHS MEDICAL ASD, INC. |
| 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 | 2007-09-17 |
| Catalog Number | 4699P-1 |
| Lot Number | 1175506 |
| Device Expiration Date | 2009-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 907231 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DR. KEENE NH 03431 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-09-17 |