MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-04-13 for PALINDROME 8888145043P manufactured by Covidien Manuf. Solutions Sa.
[72706466]
An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[72706467]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states once the catheter was implanted and after having removed the metal guide, the vena trac was withdrawn; the first without a problem. The second, when removed, broke at the beginning of the extensions of the catheter leaving the rest of the venatrack in the interior, so it was necessary to replace the catheter.
Patient Sequence No: 1, Text Type: D, B5
[83750668]
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 physical sample involved in the reported incident was not returned for evaluation. One photo was provided by the customer. Visual evaluation of this photo was performed and it was observed that the catheter was inside the patient. Also, in this picture, it was observed one stylet was broken and showed signs of manipulation. As part of the testing, the complaints technician tried to replicate the issue by trying to remove the stylet when it was still attached to the guide wire. This caused a force on the arterial lumen stylet that causes it to break similar in appearance to the reported issue. An ishikawa diagram was used to determine the potential causes for this event. According to the photo evaluation, the reported condition was identified and con firmed. A manufacturing issue could not be related to the reported condition per the available information. The most probable cause was identified as customer misuse, inadequate manipulation of the components. No triggers or trends were identified and no harm was reported in this complaint therefore further corrective and preventive actions (capa) are not required at this moment. It must be noted that in-process controls, such as personnel training, incoming quality acceptance testing for raw material, 100% visual inspection, and visual acceptance sampling, are in place to prevent nonconforming product from leaving the manufacturing operations. No additional actions are required. This complaint will be used for tracking and trending purposes. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[83750669]
The customer states once the catheter was implanted and after having removed the metal guide, the vena trac was withdrawn; the first without a problem. The second, when removed, broke at the beginning of the extensions of the catheter leaving the rest of the venatrack in the interior, so it was necessary to do the procedure again and to do the replacement of the catheter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05077 |
| MDR Report Key | 6490060 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-03-30 |
| Date Mfgr Received | 2017-06-07 |
| Device Manufacturer Date | 2016-06-03 |
| Date Added to Maude | 2017-04-13 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MANUF. SOLUTIONS SA |
| Manufacturer Street | EDIFICIO 820 CALLE#2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA 20101 |
| Manufacturer Postal Code | 20101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PALINDROME |
| Generic Name | CATHETER, HEMODIALYSIS, IMPLANTED, COATED |
| Product Code | NYU |
| Date Received | 2017-04-13 |
| Model Number | 8888145043P |
| Catalog Number | 8888145043P |
| Lot Number | 1615300164 |
| Device Expiration Date | 2019-05-03 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN MANUF. SOLUTIONS SA |
| Manufacturer Address | EDIFICIO 820 CALLE#2 ZONA FRANCA COYOL ALAJUELA 20101 20101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-13 |