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

Model Number	10-1281
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Because the device was not returned for evaluation, the root cause was unable to be determined at this time.The report does not specify the clamp detached; therefore, it is determined the clamp dislodged.No updated fmea (failure mode, effects, and criticality analysis) is required for this failure mode.Per the fema that is on file, the risk analysis file was reviewed for potential causes for the clamp becoming dislodged from the umbilical cord.The following potential causes were identified: improper material selection, raw material defective or out of specification, design error, manufacturing error, clinician error or misapplication, shipping/handling error, packaging error, and/or storage error.There has been no change to the material used to manufacture the product.The certificate of analysis for the raw material are to be reviewed to ensure the certificate states conformance to established specifications.The raw material lot numbers used to manufacture the reported lot were reviewed and all are acceptable per the ranges on the certificate.The raw material lots used in the reported lot were used in other umbilical cord clamp production lots with no external reports against those finished lot numbers.Inventory in stock was evaluated to ensure there were no abnormalities in the latch and teeth area that could potentially contribute to this occurrence.There were no issues detected during the evaluation.Due to no sample return, an evaluation cannot occur to determine if the affected clamp had a manufacturing defect.Since 2019, (b)(4) cases of product 10-1281 were sold with 1 complaint filed against it, yielding a complaint-to-sales ratio of (b)(4).The 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.The inital report was late due to waiting for defective sample to be returned.
Event or Problem Description
There was a near miss involving the clamp failure and baby lost a lot of blood while breastfeeding.

• Brand Name: UMBILICAL CORD CLAMP
• Common Device Name: UMBILICAL DEVICE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 300 debusk lane; powell TN 37849
• MDR Report Key: 12106735
• Report Number: 1057404-2021-00001
• Device Sequence Number: 19987529
• 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): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 10-1281
• Device Catalogue Number: 10-1281
• Device Lot Number: 53428537
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1