MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for TENCKHOFF CATH T202 8888411405 manufactured by Covidien.
[30048308]
Submit date: (b)(6) 2015. An investigation is currently under way; upon completion he results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[30048309]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter. The customer reports the catheter was implanted on (b)(6) 2011. The patient would use gauze to cover the baxter titanium adapter and the patient found the gauze was wet on (b)(6) 2015. The patient returned to the hospital to check the catheter and they found the catheter had a hole. The current condition of the patient is not reported. The patient was involved and there was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[36810260]
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. A sample was received for evaluation. A visual inspection was performed and part of the tube presented signs of use. A hole was found on the tubing. Marks were also found on the tip of the tubing which can be related to the placement of the titanium adapter. The device was in use for three years; therefore, the device was most likely damaged during use. The titanium adapter is separate from the catheter and is assembled by a professional during catheter implantation. The adapters are formed by two pieces that are screwed together on the silicone tubing to be installed. As per the instructions for use, it is necessary to perform a visual inspection before using the device. Do not use the catheter or components if they appear damaged or defective. Exercise caution when using sharp instruments near the catheter. Catheter tubing can tear when subjected to excessive force or rough edges. The tubing may have been damaged by the titanium adapter. A corrective action is not required at this time. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling) are in place to prevent non-conforming product from leaving the manufacturing operations. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009211636-2015-00426 |
| MDR Report Key | 5181990 |
| Date Received | 2015-10-27 |
| Date of Report | 2015-10-22 |
| Date of Event | 2015-10-21 |
| Date Mfgr Received | 2016-01-25 |
| Date Added to Maude | 2015-10-27 |
| 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 | 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 | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TENCKHOFF CATH T202 |
| Generic Name | DIALYSIS CATHETER |
| Product Code | NFK |
| Date Received | 2015-10-27 |
| Model Number | 8888411405 |
| Catalog Number | 8888411405 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-10-27 |