MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2012-08-30 for SILCON THORACIC CATH 28FR 8888572552 manufactured by Covidien.
[15779785]
It was reported to covidien on (b)(4) 2012, that a customer had an issue with a thoracic catheter. The customer reported, upon removal of the device from the pt's chest, it was noted that a piece of the device was missing. After an x-ray, it was confirmed that a 15 cm piece of the device remained in the pt. A thoracotomy procedure was done to remove the catheter piece.
Patient Sequence No: 1, Text Type: D, B5
[15943141]
Submit date 08/30/2012. An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2012-00020 |
| MDR Report Key | 2729326 |
| Report Source | 01,06 |
| Date Received | 2012-08-30 |
| Date of Report | 2012-08-01 |
| Date of Event | 2012-07-22 |
| Date Facility Aware | 2012-07-22 |
| Report Date | 2012-08-01 |
| Date Reported to Mfgr | 2012-08-01 |
| Date Mfgr Received | 2012-08-01 |
| Date Added to Maude | 2012-09-13 |
| 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 | SHARON SELBY |
| Manufacturer Street | 15 HAMPSHIRE ST. |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD INSURGENTES LIBRIAMENTO 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 | SILCON THORACIC CATH 28FR |
| Generic Name | THORACIC CATHETER |
| Product Code | GBS |
| Date Received | 2012-08-30 |
| Model Number | 8888572552 |
| Catalog Number | 8888572552 |
| Lot Number | U1290355 |
| 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 LIBRIAMENTO TIGUANA, BC MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-08-30 |