MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 99 report with the FDA on 2008-08-14 for MEDICHOICE UMBILICAL CORD CLAMP 1773088101 NA manufactured by Changzhou Concorde Plastic Products Co., Ltd.
[895078]
A problem was brought to our attention with the item 1773088101 umbilical cord clamp. The clamp was used on an infant in conjunction with another device called the "my child infant protection system". This device is a transponder that is attached to the hinge of the umbilical cord and acts as a security device in the event of child abduction from a hospital setting. The baby was nursing on the mother when a 20 minute check was performed. Once the baby was removed from the mother, the nurse noticed that the blanket was soaked with approximately 50cc of blood. The amount of blood was determined by weighing the wet blanket against a dry blanket. The nurse also noticed that the cord clamp was not closed and locked properly, because the umbilical cord was large with the artery on the side. Both the mother and child are diabetic. The baby was moved to the neonatal icu to monitor the blood sugar levels after the incident. The baby was subsequently discharged from the hospital. As a result of this incident, the hospital has instructed its nurses to use two clamps with hinges opposed to large cords.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1451040-2008-00001 |
| MDR Report Key | 1114423 |
| Report Source | 99 |
| Date Received | 2008-08-14 |
| Date of Report | 2008-08-14 |
| Date of Event | 2008-07-16 |
| Date Facility Aware | 2008-07-21 |
| Report Date | 2008-08-14 |
| Date Reported to FDA | 2008-08-14 |
| Date Reported to Mfgr | 2008-08-14 |
| Date Added to Maude | 2009-11-18 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | MEDICHOICE UMBILICAL CORD CLAMP |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2008-08-14 |
| Model Number | 1773088101 |
| Catalog Number | NA |
| Lot Number | SG08-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 11 MO |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CHANGZHOU CONCORDE PLASTIC PRODUCTS CO., LTD |
| Manufacturer Address | HUADU INDUSTRY AREA QUINHUANG TOWN WUJIN, CHANGZHOU, JINGSU 213173 CH 213173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2008-08-14 |