MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-11-08 for SMARTIP MED-PREP CANNULA 8881540111 manufactured by Covidien.
[166322247]
The incident sample has been requested but to date has not been received for evaluation.? If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.? As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Patient Sequence No: 1, Text Type: N, H10
[166322248]
The customer reported that the certified registered nurse anesthetist noted visible black particles in the monojet needleless blunt cannula. This was noted when the medication was drawn up, which was not given to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017768-2019-00729 |
| MDR Report Key | 9298011 |
| Report Source | USER FACILITY |
| Date Received | 2019-11-08 |
| Date of Report | 2019-11-08 |
| Date of Event | 2019-10-04 |
| Date Mfgr Received | 2019-10-16 |
| Date Added to Maude | 2019-11-08 |
| 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 | 5086183640 |
| 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 | 2019-11-08 |
| Model Number | 8881540111 |
| Catalog Number | 8881540111 |
| Lot Number | 923832 |
| 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 | 2019-11-08 |