MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-11-25 for SILCON THORACIC CATH 28FR 8888572552 manufactured by Covidien.
[5010194]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a thoracic catheter. The customer reports that when removing the catheter from the patient, a piece of the device had broken and remained inside of the patient. The patient had to be subjected to general anesthesia in order to extract the broken piece. The exact date of the incident is unknown.
Patient Sequence No: 1, Text Type: D, B5
[12575676]
(b)(4). An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[25281768]
A device history record review could not be performed because a lot number was not received with the complaint. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. Because a sample was not returned, we were unable to perform a thorough follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis. Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures. In addition the catheter has no loose parts and is a one piece soft catheter; therefore the broken piece cannot be of this catheter. The possible root cause for the broken device could be damaged by the user during their process. For this complaint the exact root cause and corrective actions could not be identified since the sample was not received for evaluation. No corrective actions are deemed necessary at this time. If additional information is obtained, or the sample is returned, this file will be re-opened for further investigation. This complaint will also be used for qa tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2014-00053 |
| MDR Report Key | 4277158 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-11-25 |
| Date of Report | 2014-11-24 |
| Date of Event | 2013-09-02 |
| Date Mfgr Received | 2015-05-20 |
| Date Added to Maude | 2014-12-04 |
| 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 | 0 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA |
| Manufacturer City | TIJUANA |
| 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 | 2014-11-25 |
| Model Number | 8888572552 |
| Catalog Number | 8888572552 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-25 |