MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-12-21 for N/A 401-790M 407-790M manufactured by .
[2500219]
It was reported that two sheath introducer packages were not sealed when they were being pulled for a procedure at the user facility. The devices were never used.
Patient Sequence No: 1, Text Type: D, B5
[9564568]
Stryker sustainability solutions (sss) resterilized the complaint device through our open-but-unused process. The devices were returned to sss in their original packaging. Upon inspection, the pouches were found to be unsealed at the seal opposite of the chevron seal. It was evident the pouches had no seal marks to indicate they had been sealed at some point. The most likely cause for the devices not being sealed is likely due to an oversight by in-house operators. Corrective actions are being implemented to include additional instructions for seal inspection. Personnel responsible for open-but-unused packaging will be retrained. The reported event is not occurring more frequently or with greater severity than is usual for the device.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2090040-2011-00038 |
| MDR Report Key | 2384278 |
| Report Source | 05,06,07 |
| Date Received | 2011-12-21 |
| Date of Report | 2011-12-02 |
| Date of Event | 2011-12-02 |
| Date Mfgr Received | 2011-12-02 |
| Device Manufacturer Date | 2011-09-15 |
| Date Added to Maude | 2011-12-21 |
| 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 | MS. MOIRA BARTON-VARTY |
| Manufacturer Street | 1810 W DRAKE DR |
| Manufacturer City | TEMPE AZ 85283 |
| Manufacturer Country | US |
| Manufacturer Postal | 85283 |
| Manufacturer Phone | 4807635300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | N/A |
| Generic Name | OEX |
| Product Code | OEX |
| Date Received | 2011-12-21 |
| Returned To Mfg | 2011-12-07 |
| Model Number | 401-790M |
| Catalog Number | 407-790M |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-12-21 |