The cord clamp is a component of this pack, which we purchase bulk non-sterile. The mfr of the clamp has been notified and asked to investigate. Qfc part number: qfc-650. Qfc lot number: 163-97. Qfc responses rec'd on 10-24-97 and 10-27-97 indicate: testing of samples from lot in question were rec'd and regular product testing was performed. It was confirmed that when the clamp is closed tightly enough to engage the locking mechanism the clamp does remain in a closed position. Production and inspection records in qc files were reviewed and revealed acceptance by production and inspection. Qfc has taken the following corrective actions: 1. Teeth are being adjusted to give complete closure when clamp is in closed position. 2. Outside teeth radius is being reduced to give an improved gripping effect. 3. Finish of teeth area is being changed from a polished finish to an edm finish, to improve gripping.

The infant was less than 3 hrs old. The surgeon had clamped and cut the umbilical cord the infant was then passed to the mother to see her infant. The nurse took the infant approx 4 feet to the infant warmer for add'l cleaning and routine. The rn turned to complete the infants chart and upon returning to the infant noticed bleeding through the infants wrap. Upon examination it was noticed that the cord clamp had opened partially and fell off. A kelly clamp was placed on the umbilical cord until another cord clamp was obtained and placed on the infant. No add'l med treatment was done.