MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2009-07-24 for ARGYL CON TUBE N-C 7MM X 3.1M STRL 8888301713 manufactured by Covidien.
[1227361]
It was reported to covidien on 07/20/2009 that a customer had a problem with a connecting tube. The customer states that while in use, the blue grip disengaged and fell into the patient cavity. The customer reports that it was able to be retrieved.
Patient Sequence No: 1, Text Type: D, B5
[8480771]
(b) (4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2009-00023 |
| MDR Report Key | 1468273 |
| Report Source | 01,06,07 |
| Date Received | 2009-07-24 |
| Date of Report | 2009-07-20 |
| Date of Event | 2009-06-12 |
| Report Date | 2009-07-20 |
| Date Reported to Mfgr | 2009-07-20 |
| Date Mfgr Received | 2009-07-20 |
| Date Added to Maude | 2009-12-01 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | JANICE NEVIUS |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA, CP 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYL CON TUBE N-C 7MM X 3.1M STRL |
| Generic Name | CONNECTING TUBE |
| Product Code | GCD |
| Date Received | 2009-07-24 |
| Returned To Mfg | 2009-07-13 |
| Model Number | 8888301713 |
| Catalog Number | 8888301713 |
| Lot Number | 906204664 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA, CP 22500 MX 22500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-07-24 |