MAUDE Adverse Event Report: V. MUELLER PEAN CLAMP

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  malfunction  

Event Description

Pean broke near the joint of the handle while clamping the umbilical cord.No injury to the patient, but resulted in a cut to the physician's glove.Hand examined and no cut noted.Dates of use: (b)(6) 2014.

• Brand Name: PEAN CLAMP
• Type of Device: PEAN CLAMP
• Manufacturer (Section D): V. MUELLER
• MDR Report Key: 4209355
• MDR Text Key: 16991396
• Report Number: MW5038854
• Device Sequence Number: 1
• Product Code: GEN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR