MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-01-07 for 5FR DUAL-LUMEN UVC CATH 8888160556 manufactured by Covidien.
[174094569]
Since no lot number was identified, a manufacturing device history review (dhr) 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. The actual sample involved in the reported incident was not returned for evaluation. No additional information, pictures or videos were received. Consequently, it was not possible to evaluate it as part of a comprehensive failure investigation. No probable cause was found since no sample, picture or video were received for testing, and therefore the defect is not confirmed. If the sample is returned in the future, this complaint will be re-opened for further investigation. 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 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
[174094570]
The customer reported that the line was due to be changed. The flash rn was trying to flush the line at the max zero and the line started leaking through the umbilicus while she flushed it. Both lumens were the same. The nurse called the nnp. The nnp came to bedside and ordered x-ray. Piv was started by the rn. The patient's glucose was checked and was 38. D10w bolus was given. They started iv fluids via iv. The uvc was clamped and picc was placed to run d30/tpn/il.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009211636-2020-00680 |
| MDR Report Key | 9560342 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-01-07 |
| Date of Report | 2020-02-18 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-12-10 |
| Date Added to Maude | 2020-01-07 |
| 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 | JILL SARAIVA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5086183640 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | EDIFICIO B20 CALLE #2 ZONA FRA |
| Manufacturer City | ALAJUELA |
| Manufacturer Country | CS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5FR DUAL-LUMEN UVC CATH |
| Generic Name | CATHETER, UMBILICAL ARTERY |
| Product Code | FOS |
| Date Received | 2020-01-07 |
| Model Number | 8888160556 |
| Catalog Number | 8888160556 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | EDIFICIO B20 CALLE #2 ZONA FRA ALAJUELA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-07 |