MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. UMBILICAL CORD CLAMP; DEVICE, OCCLUSION, UMBILICAL

Model Number	6833
Medical Device Problem Codes	Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: a root cause could not be determined.A valid lot number was not provided for the investigation process.The defective sample was not provided for evaluation.The samples available for evaluation stayed close with the exception of one clamp.When the clamp that failed to stay on was reapplied, it stayed close.Corrective action: none due to the root cause determination.Investigation summary: an internal complaint (call (b)(4)) was received for an umbilical cord clamp (part 6833) that failed to stay close during use.The sample was not returned for evaluation.Additionally, the lot number initially provided was not valid.Follow up was performed to obtain a valid lot number, but the information was not able to be obtained.Because a valid lot could not be obtained, the complaint investigator was unable to check the device history record.Twenty devices of a lot on hand were clamped onto a piece of neoprene foam.The clamps were clicked shut as indicated in the instructions for use.One clamp popped open.Upon further evaluation of this clamp, flash was discovered in the latch area.The amount of flash was in tolerance according to the manufacturing specification.This clamp was reapplied to the neoprene foam and left for 24 hours.This time it did not pop off and stayed applied to the foam for the full 24 hours.Since (b)(6) 2018, (b)(4) units have been sold.During this timeframe, there have been two complaints, yielding a complaint-to-sales ratio of (b)(4).There has been one other like complaint reported during this timeframe.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
Physicians have complained that the clamp isn't sturdy enough to hold when placed on the umbilical cord, which is causing the clamp to pop off.

• Brand Name: UMBILICAL CORD CLAMP
• Common Device Name: DEVICE, OCCLUSION, UMBILICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• MDR Report Key: 10657643
• Report Number: 1060680-2020-00004
• Device Sequence Number: 3058404
• Product Code: FOD
• UDI-Device Identifier: 50749756173792
• UDI-Public: 50749756173792
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/09/2020

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
• Operator of Device: Health Professional
• Device Model Number: 6833
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1