MAUDE Adverse Event Report: COVIDIEN; CORD CLAMP CLIPPER

Catalog Number 21333

Device Problem Insufficient Information (3190)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 01/18/2015

Event Type  No Answer Provided  

Event Description

Nurse was assessing baby and identified bleeding from the baby's right hand, pinky finger.Prior to nurse observing bleeding finger, nurse had used cord clamp cutter to remove cord clamp.Infant's hands were not near cord clamp cutter blade when nurse was removing cord clamp.It is believed that pinky may have come in contact with the hinge of the device causing the laceration.Pressure immediately applied and physician notified.Wound irrigated and dressed.Orthopedics consulted and closed wound with histoacryl.Finger remained warn, pink, and newborn was able to move spontaneously.Newborn was discharged the following afternoon as planned with scheduled follow-up appointment with orthopedic physician.Reason for report perhaps a shield on the device or an improvement in the design would be considered.

• Type of Device: CORD CLAMP CLIPPER
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 4527679
• MDR Text Key: 5408887
• Report Number: 4527679
• Device Sequence Number: 1
• Product Code: HDJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Nurse
• Device Catalogue Number: 21333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 02/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DAY