MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-22 for COVIDIEN ENDO CATH II AUTO SUTURE, 15 MM 173049 manufactured by Covidien.
[146231357]
Product reported by pr/surgery staff to have torn during removal of the specimen, resulting in loss of specimen and need for retrieval with another instrument. A linear slit-like tear was observed at the bottom of the bag after the procedure. Device availability: device was not captured, but lot number and expiration date were recorded. Two unused devices from the same lot number, lot j8k1975hy and exp date 09/30/2023 are available to send in to mfr.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5086868 |
| MDR Report Key | 8636979 |
| Date Received | 2019-05-22 |
| Date of Report | 2019-05-16 |
| Date of Event | 2019-05-13 |
| Date Added to Maude | 2019-05-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | COVIDIEN ENDO CATH II AUTO SUTURE, 15 MM |
| Generic Name | CONTAINER, SPECIMEN MAILER AND STORAGE |
| Product Code | KDW |
| Date Received | 2019-05-22 |
| Model Number | 173049 |
| Catalog Number | 173049 |
| Lot Number | J8K1975HY |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Brand Name | COVIDIEN ENDO CATH II AUTO SUTURE, 15 MM |
| Generic Name | CONTAINER, SPECIMEN MAILER AND STORAGE |
| Product Code | KDW |
| Date Received | 2019-05-22 |
| Model Number | 173049 |
| Catalog Number | 173049 |
| Lot Number | J8K1975HY |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN (MADE IN DOMINICAN REPUBLIC) |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-22 |