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 2017-03-23 for PALINDROME 8888123405P manufactured by Covidien Mfg Solutions S.a..
[70757385]
An investigation is currently underway; upon completion the results will be forwarded. 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
[70757386]
It was reported to covidien on (b)(6) 2017 that a customer had an issue with a dialysis catheter. The customer states there appeared to be a pin hole near the red arterial access port on the extension tube; air bubbles were seen prior to starting dialysis.
Patient Sequence No: 1, Text Type: D, B5
[86879049]
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 sample was received for analysis and investigation. Visual inspection was performed and it revealed that the catheter presented signs of use. Additionally, the clamps were reviewed and as a result irregularities were not found. The arterial extension presented marks, as if there was the use of an instrument. In order to confirm the reported condition functional testing was required. An ishikawa diagram was used to determine the potential causes for this event. The reported condition has been confirmed. Based on the available information and the results of the dhr review that showed no deviations, it can be concluded that product was manufactured according to specifications and the device functioned as intended for an undetermined amount of time. Moreover, 100% devices are inspected for leaks or cuts in the extensions per procedure. Therefore, the most probable root cause can be considered as misuse. This issue was more likely damaged caused during use due to the use of strong cleaning agents, excessive force during of use, repeated clamping or other similar damage. The evidence provided is enough to discard 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, therefore, 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 (b)(4) material, 100% in process visual inspection, leak testing and visual acceptance sampling, are in place to prevent nonconforming product from leaving the manufacturing operations. As per procedure, manufacturing performs 100% leak testing at the final stage of production, which would identify this issue in the catheter assembly. 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
[86879050]
The customer states there appeared to be a pin hole near the red arterial access port on the extension tube; air bubbles were seen prior to starting dialysis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2017-05046 |
| MDR Report Key | 6427952 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-23 |
| Date of Report | 2017-05-17 |
| Date of Event | 2017-03-09 |
| Date Mfgr Received | 2017-06-20 |
| Date Added to Maude | 2017-03-23 |
| 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 MFG SOLUTIONS S.A. |
| Manufacturer Street | EDIFICIO B20, CALLE #2 ZONA FRANCA COYOL |
| Manufacturer City | ALAJUELA 0101 |
| Manufacturer Postal Code | 0101 |
| 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 | 2017-03-23 |
| Returned To Mfg | 2017-04-24 |
| Model Number | 8888123405P |
| Catalog Number | 8888123405P |
| Lot Number | 1507600083 |
| 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 MFG SOLUTIONS S.A. |
| Manufacturer Address | EDIFICIO B20, CALLE #2 ZONA FRANCA COYOL ALAJUELA 0101 0101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-23 |