MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L UMBILICAL CORD CLAMP, 100/CS, UMBILICAL CORD CLAMP, 100/CS; DEVICE, OCCLUSION, UMBILICAL

Model Number	6833
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported, "when our nicu responder was with a new patient placing a cord clamp, she was unable to get it to stay locked and the clamp continued to bounce open." deroyal industries has requested that the sample be returned.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information becomes available.
Event or Problem Description
A user facility reported, "when our nicu responder was with a new patient placing a cord clamp, she was unable to get it to stay locked and the clamp continued to bounce open.".
Additional Manufacturer Narrative
A user facility reported, "when our nicu responder was with a new patient placing a cord clamp, she was unable to get it to stay locked and the clamp continued to bounce open." the sample, and others from the same lot, were returned to deroyal.Each of the samples were reviewed for deformities from molding, but no deformities were identified.Each sample was also applied to tubing.All devices snapped closed and did not pop open.Production records were reviewed for the lots returned, and no manufacturing issues could be identified.Pressure tests that are conducted at the end of production to ensure each sample closes with the proper amount of pressure were reviewed.Each sample was within the acceptable range.Shipping, packaging, and storage errors were also ruled out based on observations and testing.A complaint to sales ratio was conducted for the past two years and was found to be (b)(4).Root cause: based on testing and production record reviews, the problem could not be reproduced or identified.Because of this, no root cause could be established.Corrective and preventive actions: because no root cause could be established, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends surrounding this item and issue.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if more information becomes available.

• Brand Name: UMBILICAL CORD CLAMP, 100/CS, UMBILICAL CORD CLAMP, 100/CS
• Common Device Name: DEVICE, OCCLUSION, UMBILICAL
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19950661
• Report Number: 3004605321-2023-00004
• Device Sequence Number: 12997256
• Product Code: FOD
• UDI-Device Identifier: 50749756173792
• UDI-Public: 50749756173792
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup
• Report Date (Section B): 11/17/2023

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
• Device Lot Number: 59423471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown