MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-06 for ARGYLE 8888572545 manufactured by Covidien.
[74586203]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[74586204]
The customer reports the doctor had placed the chest tube during open heart and was being removed on (b)(6) 2017 when it broke off into the patient. The customer further reports they had to do surgery to remove the broken catheter.
Patient Sequence No: 1, Text Type: D, B5
[109647408]
A query of non conformance reports (ncr)? S was reviewed and confirmed that there is no ncr for this lot number. Since this complaint has been pending additional information from the customer for a period of more than 60 days and as the sample is not available for evaluation nor were photographs provided the issue could not be confirmed. The root cause and corrective actions could not be identified since the sample was not received for evaluation. This complaint will be closed with no further action; if sample is available later on, the complaint will be reopen for updated if it? S required. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2017-05068 |
| MDR Report Key | 6550785 |
| Date Received | 2017-05-06 |
| Date of Report | 2017-12-19 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-04-07 |
| Date Added to Maude | 2017-05-06 |
| 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 | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA,MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARGYLE |
| Generic Name | CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY |
| Product Code | GBS |
| Date Received | 2017-05-06 |
| Model Number | 8888572545 |
| Catalog Number | 8888572545 |
| Lot Number | 162950135 |
| 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 | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA,MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-06 |