MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-13 for MYCHILD INFANT SECURITY SYSTEM 62521 37219 manufactured by Mcroberts Security Technologies.
[77742550]
After delivery, a new umbilical security clip was applied to the newborn's umbilical cord. When the pt was moved, the clip slipped off of the cord (did not unclip) requiring the nurse to have to grab the cord to stop the bleeding. Examination of the clip shows that light shines between the teeth of the clip, which is different than other clips. Nursing staff reports this is the second similar occurrence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5070409 |
| MDR Report Key | 6642893 |
| Date Received | 2017-06-13 |
| Date of Report | 2017-06-13 |
| Date of Event | 2017-06-12 |
| Date Added to Maude | 2017-06-15 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MYCHILD INFANT SECURITY SYSTEM |
| Generic Name | UMBILICAL CORD CLAMP |
| Product Code | HFW |
| Date Received | 2017-06-13 |
| Model Number | 62521 |
| Catalog Number | 37219 |
| Lot Number | 130872 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MCROBERTS SECURITY TECHNOLOGIES |
| Manufacturer Address | 46 THROCKMORTON STREET FREEHOLD NJ 07728 US 07728 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-13 |