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 2017-02-03 for UNKNOWN DIALYSIS manufactured by Covidien Manuf. Solutions Sa.
[66445100]
Submit date: 2/3/2017. An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[66445101]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states that the patient found a little hole close to the outlet tube on (b)(6) 2017. The patient informed is due to iodophor disinfection outlet tube and tube corrosion caused infection, then got peritonitis. The patient accepted antibiotic medicine treatment but forget the name of the antibiotic. Now the patient has stopped dialysis.
Patient Sequence No: 1, Text Type: D, B5
[72893915]
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. As no lot number was identified, a manufacturing device history record (dhr) review or product/process changes review for the involved lot number could not be performed. However, all dhrs are reviewed for accuracy prior to a product release. If the sample is returned in the future, this complaint will be re-opened for further investigation. The available information was analyzed and it did not allow confirming a root cause for the event. No trends or triggers have been found, therefore, a corrective or preventive action is not deemed necessary at this time. More information was requested from the customer and no additional evidence was provided for this analysis. Based on the limited information received, this most likely could be a pd catheter. The pd manufacturing process was reviewed. Tubing is a purchased component, accepted after an incoming sampling inspection per procedure. The catheter is assembled manually and 100% visually inspected for nicks, cuts or blemishes that do not mee t drawing specifications. In addition, this catheter is subject to sampling inspection and a sterilization cycle. The adapter used in this catheter is assembled during insertion by the physician. The evidence provided is not enough to relate this event to the manufacturing operations. Additionally, there are a number of alternatives in the field like exposure to contaminating agents, or manipulation that may cause the reported infection. The instructions for use (ifu) indicate that infection is considered as a potential late complication inherent to this medical procedure and therefore it is not necessarily related to the devices performance. 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. Manufacturing performs 100% visual inspection during production, which would identify this issue in the catheter assembly. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
[72893916]
The customer states that the patient found a little hole close to the outlet tube on (b)(6) 2017. The patient informed that it is due to iodophor disinfection outlet tube and tube corrosion caused infection, and then got peritonitis. The patient accepted antibiotic medicine treatment but forgets the name of the antibiotic. Now the patient has stopped dialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-00104 |
| MDR Report Key | 6299679 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-02-03 |
| Date of Report | 2017-01-12 |
| Date of Event | 2017-01-11 |
| Date Mfgr Received | 2017-04-11 |
| Date Added to Maude | 2017-02-03 |
| 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 | UNKNOWN DIALYSIS |
| Generic Name | DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 2017-02-03 |
| 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 | 1. Other | 2017-02-03 |