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 2017-01-11 for DIALYSIS UNKNOWN UNKNOWN DIALYSIS UNK DY manufactured by Covidien.
[64522503]
An investigation is currently underway. Upon completion, the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[64522504]
It was reported to covidien on 12/20/2016 that a customer had an adverse event with a dialysis catheter. The customer states that a patient was hospitalized with peritonitis caused by a little hole near the titanium joints of the catheter. The patient accepts antibiotics medicine treatment. The patient has stopped dialysis. The broken part of the catheter was cut off and the catheter is still in use. The catheter was implanted on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[69792203]
Submit date: 03/04/2017. An investigation was performed. This complaint has not been confirmed. The actual sample involved in the reported incident was not returned for evaluations. No additional information, pictures or videos were received. Since no sample was returned for examination, it was not possible to evaluate it as part of a comprehensive failure investigation. 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 device history records (dhr) are reviewed for accuracy prior to product release. No sample or additional information was received for testing and investigation. If the sample is returned in the future, this complaint will be re-opened for further investigation. No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time. It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for (b)(4) material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) 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 | 3009211636-2017-00011 |
| MDR Report Key | 6242877 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-01-11 |
| Date of Report | 2016-12-20 |
| Date Mfgr Received | 2017-03-04 |
| Date Added to Maude | 2017-01-11 |
| 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 STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN MANUFACTURING SOLUTIONS SA |
| Manufacturer Street | 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 | DIALYSIS UNKNOWN |
| Generic Name | DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 2017-01-11 |
| Model Number | UNKNOWN DIALYSIS |
| Catalog Number | UNK DY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-01-11 |