MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-03 for UMBILI-CLAMP CLW-1005-A01 manufactured by Divergent Medical Technologies.
[68997994]
Patient Sequence No: 1, Text Type: N, H10
[68997995]
Mother had requested that infant was to be placed skin to skin immediately after delivery. Tot guard/umbilical clamp was place on infant at delivery by nicu rn. We have received education regarding clamp placement (i. E don't slide clamp along cord, this causes shredding) infant was dried and placed skin to skin immediately. Infant was taken from mother and placed in radiant warmer. It was noted that there was a small amount of fresh blood on infants abdomen/ thighs and cord clamp. Area was cleaned and it was noted that blood was slowly oozing from umbilical cord. An additional cord clamp (the ones we used previously prior to implementation of tot guard) was placed underneath the tot guard clamp. Oozing stopped after placement of 2nd clamp. Infant was placed on scale and weighed, then moved back to radiant warmer. Tot guard/ umbilical clamp fell off into bed. Clamp was still intact (closed) but had slid off of umbilical cord. There have been other reports of this product not closing tightly or shearing umbilical cord at our facility and another facility. This concern has previously been discussed amongst staff and with management that these clamps are loose and worrisome. This could have been a serious safety event had it not been for vigilant staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6376018 |
| MDR Report Key | 6376018 |
| Date Received | 2017-03-03 |
| Date of Report | 2017-02-14 |
| Date of Event | 2016-12-01 |
| Report Date | 2017-02-14 |
| Date Reported to FDA | 2017-02-14 |
| Date Reported to Mfgr | 2017-02-14 |
| Date Added to Maude | 2017-03-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | 3 |
| Brand Name | UMBILI-CLAMP |
| Generic Name | DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2017-03-03 |
| Model Number | CLW-1005-A01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIVERGENT MEDICAL TECHNOLOGIES |
| Manufacturer Address | 5 FIR CT STE 1A OAKLAND NJ 07436 US 07436 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-03 |