MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-05 for STR THOR CATH 28FR 8888570549 manufactured by Covidien.
[35381487]
Submit date 01/05/2016. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[35381488]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a thoracic catheter. The customer states the holes at the end of the catheter still had a piece of the original material in it. The excess material was removed by the doctor and they were able to utilize the tube for the procedure.
Patient Sequence No: 1, Text Type: D, B5
[43868942]
The device history record (dhr) was reviewed. The dhr file indicated that the product was released accomplishing all quality standard requirements. There were no non-conforming issues reported during the production of this product for a similar condition as reported in this complaint. A sample without original package or lot number was received for evaluation. The reported condition was confirmed. After performing a visual inspection the issue was observed in the product. According to the physical sample received, the eye slug was not completely removed from the thoracic catheter. After reviewing the process line where the product is being manufactured, the most likely root cause detected was waste on the mandrels and mandrel misalignment during the cutting process. New mandrels and cutting tools will be purchased to replace the actuals. The cycle of duration life for the mandrels and cutting tools will be defined. The operator is performing 100% visual inspection for eye slugs present on the catheter tip. If additional information is received warranting further analysis, the investigation will be resumed. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2016-00001 |
| MDR Report Key | 5343590 |
| Date Received | 2016-01-05 |
| Date of Report | 2016-01-04 |
| Date of Event | 2015-12-30 |
| Date Mfgr Received | 2016-04-27 |
| Device Manufacturer Date | 2015-06-13 |
| Date Added to Maude | 2016-01-05 |
| 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 ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL |
| Manufacturer City | TIJUANA 22500 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STR THOR CATH 28FR |
| Generic Name | THORACIC CATHETER |
| Product Code | GBS |
| Date Received | 2016-01-05 |
| Model Number | 8888570549 |
| Catalog Number | 8888570549 |
| Lot Number | 515308264X |
| 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 | CALLE 9 SUR NO. 125 CUIDAD INDUSTRIAL TIJUANA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-05 |