MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-12-21 for PALINDROME EMERALD 23/40KIT VT 8888145044 manufactured by Covidien.
[34739791]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[34739792]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter. The customer stated that it was found that the adapter of the catheter had a slow leak during dialysis, and was unable to perform dialysis. The venous end has a crack. The physician replaced the adapter with another new one. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[40853334]
The device history record (dhr) was reviewed and no deviations related to this failure mode were found. There are no non-conformances related to the reported issue for the involved lot. The sample was returned for investigation; it consisted of one catheter of the product mahurkar, 2 dilators (10 and 12), 1 guide wire and 1 needle introducer that came inside a generic plastic bag and did not present signs of use. It was observed that the blue adapter was not presented attached to the extension of the mahurkar catheter. This catheter was not related to this complaint since a palindrome catheter was reported. A blue adapter was returned detached from the extension; it presented signs of use (remains of blood). Visual inspection was performed and the blue adapter had a crack on the thread pitch area, the crack was at 270 degrees. Additionally, the adapter presented marks that could indicate the use of some instrument. The physician replaced the adapter with another new one and it could be determined that the blue adapter returned is related to the palindrome catheter reported by this complaint. The instructions for use (ifu) state that it is necessary to perform an inspection before using the device. Do not use the catheter if it is damaged or appears defective. Over tightening catheter connections can crack some adapters. Additionally, the adapter became damaged after being in use for an undetermined amount of time. The evidence provided is not enough to relate this event to the manufacturing operations. Based on the available information and the result of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and it functioned as intended for an undetermined amount of time; for this reason the adapter was more likely damaged during use and the most possible root cause can be considered over tightening the adapter. 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 nonconforming 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 | 3009211636-2015-00517 |
| MDR Report Key | 5313209 |
| Date Received | 2015-12-21 |
| Date of Report | 2015-12-09 |
| Date of Event | 2015-12-09 |
| Date Mfgr Received | 2016-03-21 |
| Date Added to Maude | 2015-12-21 |
| 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 | PALINDROME EMERALD 23/40KIT VT |
| Generic Name | DIALYSIS CATHETER |
| Product Code | NYU |
| Date Received | 2015-12-21 |
| Model Number | 8888145044 |
| Catalog Number | 8888145044 |
| Lot Number | 307320X |
| 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 | 2015-12-21 |