MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-10-20 for ARGYLE 8888572552 manufactured by Covidien.
[89943267]
An investigation is currently under way; upon completion the results will be forwarded. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[89943268]
The customer reports the tubing of the catheter continued to break apart when the physician went to use it. They had to replace the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1282497-2017-05412 |
| MDR Report Key | 6965834 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-10-20 |
| Date of Report | 2018-01-17 |
| Date Mfgr Received | 2017-10-10 |
| Date Added to Maude | 2017-10-20 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | BOULEVARD INSURGENTES 19030 |
| Manufacturer City | TIJUANA 22225 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22225 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY |
| Product Code | GBS |
| Date Received | 2017-10-20 |
| Model Number | 8888572552 |
| Catalog Number | 8888572552 |
| Lot Number | 163330148 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | BOULEVARD INSURGENTES 19030 TIJUANA 22225 MX 22225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-20 |