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 2012-03-09 for N/A LA8SAL20 manufactured by .
[2549027]
It was reported that the guiding catheters were mislabeled. The devices were never used.
Patient Sequence No: 1, Text Type: D, B5
[9669993]
Originally, when the complaint was reported, the user facility would not release the devices to stryker sustainability solutions (sss) for an evaluation. It was unknown if the devices were mislabeled at the time and the devices were not used so there was no risk to the patient, so sss determined not to file a medical device report at that time. However, on (b)(4) 2012, the devices were returned for an evaluation. Six guiding catheters were returned for an evaluation. Stryker sustainability solutions (sss) resterilized the complaint devices through our open-but-unused process. The labels of all six devices were evaluated against the physical device properties, the om specification guide, device history records, and sss's item database. The investigation showed that one device had the correct part number but in the part description the device was listed as a 7fr size when it was actually an 8fr size. One device had the correct part number, but incorrect curve size listed on the label. Three devices had the incorrect part number listed on the label and one device was labeled correctly. Based off the investigation the most likely root cause for the two devices that had the correct part number but incorrect part description information was due to an oversight during introduction of the device type into the open-but-unused program as this process requires manual entry of the part number and description into the item database. The most likely root cause for the three devices with the incorrect part numbers was due to oversight since the device labels were likely mismatched upon their application to the device packaging. The item database has been updated and retraining was performed for packaging and pre-sterilization inspection personnel. 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 | 2090040-2012-00007 |
| MDR Report Key | 2485267 |
| Report Source | 05,06,07 |
| Date Received | 2012-03-09 |
| Date of Report | 2012-01-16 |
| Date Mfgr Received | 2012-02-15 |
| Device Manufacturer Date | 2008-10-06 |
| Date Added to Maude | 2012-08-28 |
| 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 | DQY |
| Product Code | OEX |
| Date Received | 2012-03-09 |
| Returned To Mfg | 2012-02-15 |
| Model Number | LA8SAL20 |
| Catalog Number | LA8SAL20 |
| 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 | 2012-03-09 |