MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-05-31 for 6833 UMBILICAL CORD CLAMP, 100/CS 07 manufactured by Deroyal.
[19496074]
Incident occurred about 15 minutes after cord clamping. While the infant was under the warmer, nurse noticed blood flowing through the cord clamp. Nurse applied pressure to the cord and placed a new clamp on the cord, which stopped the blood flow. Infant lost about 1cc blood, and required no additional treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1046367-2000-00019 |
| MDR Report Key | 280301 |
| Report Source | 07 |
| Date Received | 2000-05-31 |
| Date of Report | 2000-05-31 |
| Date of Event | 2000-05-02 |
| Date Facility Aware | 2000-05-02 |
| Report Date | 2000-05-31 |
| Date Reported to FDA | 2000-06-01 |
| Date Mfgr Received | 2000-05-02 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2000-06-06 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LN. |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8659387828 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 6833 UMBILICAL CORD CLAMP, 100/CS |
| Generic Name | 7N8 UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2000-05-31 |
| Model Number | 07 |
| Catalog Number | 6833 |
| Lot Number | 194854 |
| ID Number | * |
| Device Expiration Date | 2004-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 271261 |
| Manufacturer | DEROYAL |
| Manufacturer Address | 200 DEBUSK LANE POWELL TN 37849 US |
| Baseline Brand Name | UMBILICAL CORD CLAMP, 100/CS |
| Baseline Generic Name | 7N8 UMBILICAL CORD CLAMP |
| Baseline Model No | 07 |
| Baseline Catalog No | 6833 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2000-05-31 |