MAUDE Adverse Event Report: SPECTRUM SURGICAL SUPPLIES SPECTRUM KELLY CLAMP OR KELLY FORCEPS; FORCEPS, GENERAL & PLASTIC SURGERY

Device Problem Disconnection (1171)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/07/2021

Event Type  malfunction  

Event Description

Infant delivered via c/s.Cord clamped with kelly and cut.Infant handed off to ob rn.When ob rn set infant in warmer, noted blood on blanket.Was found that kelly clamp had come unclamped.Rn quickly clamped the kelly to stop bleeding.Fda safety report id # (b)(4).

• Brand Name: SPECTRUM KELLY CLAMP OR KELLY FORCEPS
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): SPECTRUM SURGICAL SUPPLIES
• MDR Report Key: 13043058
• MDR Text Key: 282560460
• Report Number: MW5106149
• Device Sequence Number: 1
• Product Code: GEN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2021

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
• Device Expiration Date: 10/07/2021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 3 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White