MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-01-22 for * 21333 manufactured by Covidien.
[5408887]
Nurse was assessing baby and identified bleeding from the baby's right hand, pinky finger. Prior to nurse observing bleeding finger, nurse had used cord clamp cutter to remove cord clamp. Infant's hands were not near cord clamp cutter blade when nurse was removing cord clamp. It is believed that pinky may have come in contact with the hinge of the device causing the laceration. Pressure immediately applied and physician notified. Wound irrigated and dressed. Orthopedics consulted and closed wound with histoacryl. Finger remained warn, pink, and newborn was able to move spontaneously. Newborn was discharged the following afternoon as planned with scheduled follow-up appointment with orthopedic physician. Reason for report perhaps a shield on the device or an improvement in the design would be considered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4527679 |
| MDR Report Key | 4527679 |
| Date Received | 2015-01-22 |
| Date of Report | 2015-01-22 |
| Date of Event | 2015-01-18 |
| Report Date | 2015-01-22 |
| Date Reported to FDA | 2015-01-22 |
| Date Reported to Mfgr | 2015-02-18 |
| Date Added to Maude | 2015-02-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | CORD CLAMP CLIPPER |
| Product Code | HDJ |
| Date Received | 2015-01-22 |
| Model Number | * |
| Catalog Number | 21333 |
| Lot Number | * |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Age | 1 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 15 HAMPSHIRE STREET MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-22 |