MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06 report with the FDA on 2014-12-18 for PALINDROME EMERALD 19/36 SPORT W/ VT 8888119365 manufactured by Costa Rica.
[20362415]
It was reported to covidien on (b)(6) 2014 that a customer had an issue with a dialysis catheter. The customer states that catheter was cracked below the hub. Patient: male, (b)(6); hd patient. No patient injury or ill-effects. Catheter was removed and replaced. The device will be returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[20532786]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[28842591]
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. The product sample returned consisted of one 14. 5 fr palindrome catheter, 19 cm implant length, 36 cm with signs of use. After a visual inspection was performed, a hole was found on the joint of the catheter below the hub. During functional testing (underwater test), bubbles were detected coming out below the hub, from the lumen which corresponds to the arterial extension. The lumen related to the venous extension did not show bubbles during the test. As per the instructions for use, the customer has to perform a visual inspection before using the device. Do not use the catheter if it appears damaged or defective. The catheter tubing can tear when subjected to excessive force or rough edges. Inspect the catheter frequently for nicks, scrapes or cuts which could impair its performance. The catheter functioned as intended for 2 years and 4 months. The issue was noticed during use. The most probable root cause could be due to damage during the medical procedure. The leak can be due to excessive force or inappropriate use of cleaning agents. The lot involved on this event was manufactured on (b)(6) 2012, before the implementation date of actions related to a corrective and preventative action. It was defined that this event is being handled through this capa and no additional actions are 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 | 3009211636-2014-00201 |
| MDR Report Key | 4341244 |
| Report Source | 01,06 |
| Date Received | 2014-12-18 |
| Date of Report | 2014-12-16 |
| Date of Event | 2014-12-05 |
| Date Mfgr Received | 2015-05-11 |
| Device Manufacturer Date | 2012-01-05 |
| Date Added to Maude | 2015-01-05 |
| 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 | 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 | 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 19/36 SPORT W/ VT |
| Generic Name | DIALYSIS CATHETER |
| Product Code | NYU |
| Date Received | 2014-12-18 |
| Model Number | 8888119365 |
| Catalog Number | 8888119365 |
| Lot Number | 200620X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COSTA RICA |
| Manufacturer Address | COVIDIEN MANUFACTURING SOLULFONS SA EDIFICIO 820 CALLE #2 ZONA FRANCA COYOL ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-12-18 |