MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-03-30 for ADD A CATH FOLEY TRAY 5029 manufactured by Covidien.
[16372454]
It was reported to covidien on 3/05/2009 that a customer had a problem with a urology tray. The customer reports that the user was stuck with a 3. 5" unsheathed competitor needle that was found inside sealed tray, folded under the thumb of the glove. Customer reports hospital protocol followed for contaminated needle stick.
Patient Sequence No: 1, Text Type: D, B5
[16503874]
(b) (4). An investigation is currently underway, upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2009-00009 |
| MDR Report Key | 1416578 |
| Report Source | 06 |
| Date Received | 2009-03-30 |
| Date of Report | 2009-03-05 |
| Date of Event | 2009-02-20 |
| Date Facility Aware | 2009-02-20 |
| Report Date | 2009-03-05 |
| Date Reported to Mfgr | 2009-03-05 |
| Date Mfgr Received | 2009-03-05 |
| Date Added to Maude | 2009-12-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616387 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 9255 CUSTOMHOUSE PLAZA, STE A |
| Manufacturer City | SAN DIEGO CA 92173 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADD A CATH FOLEY TRAY |
| Generic Name | FOLEY TRAY |
| Product Code | NWR |
| Date Received | 2009-03-30 |
| Returned To Mfg | 2009-03-10 |
| Model Number | 5029 |
| Catalog Number | 5029 |
| Lot Number | 823152764 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 9255 CUSTOMHOUSE PLAZA, SAN DIEGO CA 92173 US 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-30 |