MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for PALINDROME EMERALD 23/40KIT VT 8888145044 manufactured by Covidien.
[41766555]
Submit date: 3/30/2016 an investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[41766556]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a dialysis catheter. The customer reports it was found there was a leak with the connector of the catheter during dialysis treatment for the patient. There was a cleft (split) on the venous side. The physician replaced it with a new catheter. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[50753372]
A device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode. All quality assurance testing performed during manufacturing was acceptable. The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements. In addition, all dhrs are reviewed for accuracy prior to product release. The sample consisted of a mahurkar catheter 11. 5fr x 13. 5cm that is different than the product reported. The red adapter showed signs of use. Visual inspection was performed and it was observed that red adapter was detached from the extension and the extension was broken. A crack was found on the arterial adapter on the thread pitch area. The adapter presents marks that indicate the use of some instrument. Manufacturing performed 100% inspection for cracked adapters per procedure and the incoming inspection was performed. The instructions for use (ifu) state that the customer should perform an inspection before using the device. Additionally, the adapter became damaged after being in use for an undetermined amount of time. The reported condition has been confirmed. The evidence provided is not enough to relate this event to the manufacturing operations. The most possible root cause can be considered as misuse; the instructions for use were not followed causing adapter over tightening. No complaint triggers or trends were identified. This event will be addressed through a corrective and preventative action (capa) and health hazard evaluation (hhe), no additional actions were required. 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 | 3009211636-2016-00142 |
| MDR Report Key | 5536252 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-16 |
| Date Mfgr Received | 2016-07-18 |
| Date Added to Maude | 2016-03-30 |
| 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 | COVIDIEN MANUF. SOLUTIONS 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 | 2016-03-30 |
| 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 | 2016-03-30 |