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

Model Number	10-1281
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The umbilical cord clamps that are in our vaginal packs are hard to clamp and when it clamps it comes off easily.Unfortunately, this was not reported asap until an incident happened.It came off from a newly born baby and baby lost some blood.
Additional Manufacturer Narrative
A user facility complaint was received on 2/9/2023, reporting, "the umbilical cord clamps that are in our vaginal packs are hard to clamp and when it clamps it comes off easily.Unfortunately, this was not reported asap until an incident happened.It came off from a newly born baby and baby lost some blood." the sample is not available for return to deroyal for evaluation.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 is concluded from the investigation.
Additional Manufacturer Narrative
The sample nor a picture of the sample was not available for return to deroyal for evaluation.Root cause: without a defective sample, the root cause could not be established.Potential root cause: two potential root causes that could not be ruled out were that the part may not have been completely formed in manufacturing or there could have been a use error in application by the user.Production records were reviewed, and no issues were found.Both work orders and the failure modes and effects analysis (fmea) were reviewed and no issues were found with either.An inventory check of the umbilical clamps was made by deroyal.A total of 50 of the 10-1281 clamps were inspected and no discrepancies were identified during the inspection.Because no root cause could be established, no corrective or preventive actions were taken.Deroyal will continue to monitor for trends.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CLAMP UMBILICAL CORD
• Common Device Name: DEVICE, OCCLUSION, UMBILICAL
• 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: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19929623
• Report Number: 1057404-2023-00004
• Device Sequence Number: 2760098
• Product Code: FOD
• UDI-Device Identifier: 00749756746151
• UDI-Public: 00749756746151
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/29/2023

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: 10-1281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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