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 2012-02-22 for N/A CB5LT manufactured by .
[14886252]
It was reported that while in inventory at the user facility, it was noticed that "there is no tip protector and the trocar is puncturing a hole in the packaging. " the device was not used.
Patient Sequence No: 1, Text Type: D, B5
[15274665]
Stryker sustainability solutions (sss) resterilized the complaint device through our open-but-unused process. The complaint device was returned to sss in its original sealed packaging. The package was noticed to possess indentions in the proximity of the device tip. It was confirmed that the sterile barrier had been breached by the device tip. It was confirmed that these devices are shipped from the om without a tip protector; instead, the device is packaged in a pouch configuration that appears to prevent indentions in the packaging without the use of a tip protector. The packaging will be changed to use the same packaging requirements currently validated through the full process trocar product line in sss's (b)(4) location. 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 | 2090040-2012-00006 |
| MDR Report Key | 2464560 |
| Report Source | 05,06,07 |
| Date Received | 2012-02-22 |
| Date of Report | 2012-01-27 |
| Date Mfgr Received | 2012-01-27 |
| Device Manufacturer Date | 2011-12-13 |
| Date Added to Maude | 2012-08-23 |
| 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 | GCJ |
| Product Code | OEX |
| Date Received | 2012-02-22 |
| Returned To Mfg | 2012-02-02 |
| Model Number | CB5LT |
| Catalog Number | CB5LT |
| 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 | 2012-02-22 |