MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2008-10-10 for PRO-VENT PLUS ARTERIAL BLOOD SAMPLING KIT G1463J manufactured by Smiths Medical Asd, Inc..
[978880]
User reports blood leaked from the syringe tip and droplets entered the doctor's eye. It is unknown if the unit was examined before use. No treatment given that we have been notified of.
Patient Sequence No: 1, Text Type: D, B5
[8211566]
Results evaluations: our investigation into this event is based on the digital photos supplied by smiths medical. The sample deformity appears to be consistent with mechanical damage caused by the syringe barrel coming into contact with another ridged object during assembly. Previously, there was a dryer misalignment that was identified and corrected prior to the receipt of this complaint. It is hypothesized this dryer misalignment would cause this type of defect. The mfg records, of the two possible lots, were reviewed, and found to have no notation regarding this issue. Manufacturing has been notified of the issue, and has a heightened awareness of this type of defect. A review of our complaints database reveals no other reports on the two possible device lot numbers given. This report has been logged for trending.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1217052-2008-00099 |
| MDR Report Key | 1205708 |
| Report Source | 07 |
| Date Received | 2008-10-10 |
| Date of Report | 2008-09-18 |
| Date of Event | 2008-09-17 |
| Date Mfgr Received | 2008-09-18 |
| Date Added to Maude | 2009-11-03 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | TIMOTHY MATSON |
| Manufacturer Street | 10 BOWMAN DRIVE |
| 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 | 2008-10-10 |
| Catalog Number | G1463J |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 10 BOWMAN DRIVE KEENE NH 03431 US 03431 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-10 |