MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-03 for 8888200001 manufactured by Covidien Manuf. Solutions Sa.
[71833887]
Submit date: 04/03/2017. An investigation is currently underway; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[71833888]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states the catheter was leaking. When using a syringe there were blood drops at the extension.
Patient Sequence No: 1, Text Type: D, B5
[115232496]
Submit date: 2017-july-03 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 product release. Two photos were provided by the customer. Visual evaluation of these photos was performed. In the first picture shows a hand that is holding the extension of one catheter. In this photo it was observed a stain that seems to be remains of blood in the extension. In the second image it was observed a venous extension and in this photo it is also seen a stain that seems to be remains of blood. However, the received pictures do not allow confirming that the stains correspond to a crack or leak. Therefore, the reported condition cannot be confirmed. Additionally, the sample was received for analysis and investigation. The sample consisted of two extensions from one repair kit. Visual inspection was performed and it revealed that the extensions presented signs of use. Additionally, the extensions were reviewed and as result no issues or irregularities were found. In order to confirm the condition reported, functional tests were performed. The extensions returned were submitted to underwater test and bubbles were not detected. The design failure mode and effects analysis was reviewed in order to identify the possible root causes for this event. An ishikawa diagram was used to determine the potential causes. The reported condition has not been confirmed. Based on the available information the reported condition was not found. The probable cause can be considered as customer perception. The evidence provided does not allow linking the reported condition the manufacturing process as a potential cause. No trends or trigger were identified, no harm was reported for this complaint and this is not a manufacturing/supplier related event, no further corrective or preventive actions are not deemed necessary at this time. 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. No additional actions are required. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
[115232497]
The customer states the catheter was leaking. When using a syringe there were blood drops at the extension.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05067 |
| MDR Report Key | 6454932 |
| Date Received | 2017-04-03 |
| Date of Report | 2017-05-16 |
| Date of Event | 2017-03-20 |
| Date Mfgr Received | 2017-07-03 |
| Date Added to Maude | 2017-04-03 |
| 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 | 0 |
| Brand Name | NA |
| Generic Name | KIT, REPAIR, CATHETER, HEMODIALYSIS |
| Product Code | NFK |
| Date Received | 2017-04-03 |
| Returned To Mfg | 2017-04-26 |
| Model Number | 8888200001 |
| Catalog Number | 8888200001 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-04-03 |