MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CORD CLAMP CUTTER PREMIER PRO; UMBILICAL CORD CLAMP CUTTER

Model Number 3603PP

Device Problems Defective Device (2588); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

Event Type  malfunction  

Event Description

Users having trouble opening the cutter enough to get inside the cord clamp to remove it.Used safety pins instead, concerned about the potential for injury to patient or user by cutter or safety pin.

Manufacturer Narrative

The device was not available for return so no evaluation on the reported device could be performed.A review of the device history record and work order showed no anomalies during manufacturing.Representative lots were inspected and no discrepancies were found.No root cause was able to be determined.No further information is available at this time.If additional information is received a follow up report will be submitted.

• Brand Name: CORD CLAMP CUTTER PREMIER PRO
• Type of Device: UMBILICAL CORD CLAMP CUTTER
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• Manufacturer Contact: mary catherine reeves ; 200 debusk lane; powell, TN 37849
• MDR Report Key: 14219100
• MDR Text Key: 299364395
• Report Number: 1057404-2022-00003
• Device Sequence Number: 1
• Product Code: FZT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3603PP
• Device Lot Number: 51337471
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1