MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2011-01-24 for SILICONE THORACIC CATH 40FR 8888572586 manufactured by Covidien.
[1710654]
It was reported to covidien on (b)(6) 2011 that a customer had an issue with a silicone thoracic catheter. The customer states that while inserting the silicone chest tube into the pt, the tube fractured along the side eye holes and broke into two pieces. The customer reports first x-rays identified a kink in the tube and second x-rays identified the fracture. The customer reports surgery was required to remove the fractured piece. On (b)(6) 2011, add'l info was provided to covidien stating that the pt was doing well and was stable.
Patient Sequence No: 1, Text Type: D, B5
[9037516]
Submit date: (b)(4) 2011. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2011-00001 |
| MDR Report Key | 1993555 |
| Report Source | 06,07 |
| Date Received | 2011-01-24 |
| Date of Report | 2011-01-18 |
| Date of Event | 2011-01-18 |
| Date Facility Aware | 2011-01-18 |
| Report Date | 2011-01-18 |
| Date Reported to Mfgr | 2011-01-18 |
| Date Mfgr Received | 2011-01-18 |
| Date Added to Maude | 2011-03-07 |
| 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 ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082616283 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD INSURGENTES LIBRIAMENT A LA P, LA MESA |
| Manufacturer City | TIJUANA, BC |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE THORACIC CATH 40FR |
| Generic Name | CARDIO THORACIC CATHETER |
| Product Code | GBS |
| Date Received | 2011-01-24 |
| Model Number | 8888572586 |
| Catalog Number | 8888572586 |
| Lot Number | UNK |
| 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 | 37 BLVD. INSURGENTES LIBRAMENO TIJUANA, BC MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-01-24 |