MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2019-10-17 for SMARTIP MED-PREP CANNULA 8881540111 manufactured by Covidien.
[164434459]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[164434460]
The customer reported they found 3 blunt tip cannulas with mold inside.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017768-2019-00697 |
| MDR Report Key | 9202140 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-10-17 |
| Date of Report | 2019-10-17 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-10-07 |
| Date Added to Maude | 2019-10-17 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086172514 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 2010 EAST INTERNATIONAL SPEEDW |
| Manufacturer City | DELAND FL 32724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SMARTIP MED-PREP CANNULA |
| Generic Name | CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY |
| Product Code | GEA |
| Date Received | 2019-10-17 |
| Model Number | 8881540111 |
| Catalog Number | 8881540111 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 2010 EAST INTERNATIONAL SPEEDW DELAND FL 32724 US 32724 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-10-17 |