MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-01 for MEDICHOICE UMBILICAL CORD CLAMP 88101 * manufactured by Deroyal Industries.
[15687388]
Patient was delivered and umbilical cord was clamped and cut as usual. When applying cord clamp, a transponder was attached to the patient using the cord clamp. At change of shift assessment, nurse discovered that the umbilical cord was oozing. A new cord clamp was attached. When original clamp was inspected, it appeared to be "slightly bowed". In retrospect, nurses are not certain whether the transponder was properly aligned in the clamp. Nurses report that we have not had a similar experience in the year-plus we have been using this clamp. We will continue to monitor and review prior to reordering product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 639437 |
| MDR Report Key | 639437 |
| Date Received | 2005-09-01 |
| Date of Report | 2005-09-01 |
| Date of Event | 2005-08-26 |
| Report Date | 2005-09-01 |
| Date Reported to FDA | 2005-09-01 |
| Date Added to Maude | 2005-10-07 |
| 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 | 0 |
| 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 | MEDICHOICE UMBILICAL CORD CLAMP |
| Generic Name | CORD CLAMP |
| Product Code | HFW |
| Date Received | 2005-09-01 |
| Model Number | 88101 |
| Catalog Number | * |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 628985 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-01 |