MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-17 for EDGE FIRM TIP 180 CATHETER SDK4000-FT manufactured by Covidien Llc / Medtronic Inc..
[142614639]
Upon removal of the specimen from the catheter, there appeared to be a malfunction. A thin line of plastic became separated or sliced from the 180 catheter and came out along with the specimen (approx 53 cm).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085979 |
| MDR Report Key | 8527914 |
| Date Received | 2019-04-17 |
| Date of Report | 2019-02-01 |
| Date of Event | 2019-01-24 |
| Date Added to Maude | 2019-04-18 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | EDGE FIRM TIP 180 CATHETER |
| Generic Name | EDGE FIRM TIP 180 CATHETER |
| Product Code | KTI |
| Date Received | 2019-04-17 |
| Model Number | SDK4000-FT |
| Catalog Number | SDK4000-FT |
| Lot Number | 508312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC / MEDTRONIC INC. |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Brand Name | EDGE FIRM TIP 180 CATHETER |
| Generic Name | EDGE FIRM TIP 180 CATHETER |
| Product Code | JAK |
| Date Received | 2019-04-17 |
| Model Number | SDK4000-FT |
| Catalog Number | SDK4000-FT |
| Lot Number | 508312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN LLC / MEDTRONIC INC. |
| Manufacturer Address | MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-17 |