MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-06 for 20CM 12FR MAH HPTLC TRAY W/SE 8888102003HP manufactured by Covidien.
[30907619]
Submit date: (b)(6) 2015. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[30907620]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a dialysis catheter. The customer states that the pigtail port in the catheter was found in the bed still attached to the iv tubing and the iv was still infusing. It was detached between the tubing and end piece. The customer is unable to determine if it broke off or came apart. The remaining tubing clamp is still in place. An additional hemostat was also placed as a clamp. There was a significant amount of blood in bed in between the patients legs. The md was shown the issue immediately and labs were drawn. The patient remained alert and their blood pressure remained stable.
Patient Sequence No: 1, Text Type: D, B5
[37273079]
Submit date: (b)(6) 2016. A device history record review could not be performed because a lot number was not received with the complaint. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. A sample was received for evaluation. A visual inspection was performed and the infusion adapter port was detached from the infusion lumen. The outside diameter of the tubing and inside diameter of the adapter was measured. Both were within specifications. Glue residue was not found inside the adapter. A possible root cause can be due to an incorrect position of the tubing in the mandrel may affect the glue application through the clear adapter. As per the instructions for use, it is necessary to perform an inspection before using the device. Do not use the catheter if it is crushed, cracked, cut, or otherwise damaged. Do not infuse against a closed clamp or forcibly infuse a blocked catheter: backpressure could force the adapter out of the tubing. Do not infuse against a closed clamp or forcibly infuse a blocked catheter: back pressure could force the adapter out of the tubing. A quality alert was performed to the personnel involved in order to avoid this issue in the future. This event will be handled through a formal corrective and preventative action and no further actions are required. 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 non-conforming 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 | 3009211636-2015-00447 |
| MDR Report Key | 5207891 |
| Date Received | 2015-11-06 |
| Date of Report | 2015-10-27 |
| Date of Event | 2015-10-23 |
| Date Mfgr Received | 2016-02-01 |
| Date Added to Maude | 2015-11-06 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | COVIDIEN MANUFACTURING SOLULFONS SA 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 | 20CM 12FR MAH HPTLC TRAY W/SE |
| Generic Name | DIALYSIS CATHETER |
| Product Code | FJT |
| Date Received | 2015-11-06 |
| Model Number | 8888102003HP |
| Catalog Number | 8888102003HP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-11-06 |