MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-04-30 for COOK TRIPLE LUMEN CVL SET 1000699 5 FR 12 * manufactured by Cook Critical Care.
[223125]
Rn's noted that the pt was having increased bleeding from their central line site. Lumen #1 from the triple lumen cvl set noted to be disconnected from the plastic hub connecting all three lumens to the central line set-up. Lumen #1 broke off set and pt was bleeding. Central line was discontinued with no adverse outcome to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1021766 |
| MDR Report Key | 330414 |
| Date Received | 2001-04-30 |
| Date of Report | 2001-04-30 |
| Date of Event | 2001-04-20 |
| Date Added to Maude | 2001-05-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOK TRIPLE LUMEN CVL SET |
| Generic Name | TRIPLE LUMEN CENTRAL LINE |
| Product Code | GBP |
| Date Received | 2001-04-30 |
| Model Number | 1000699 5 FR 12 |
| Catalog Number | * |
| Lot Number | 977771 |
| ID Number | GUTLMY-501J-RSC |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 319774 |
| Manufacturer | COOK CRITICAL CARE |
| Manufacturer Address | PO BOX 489 BLOOMINGTON IN 474028335 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-04-30 |