MAUDE Adverse Event Report: AVID MEDICAL, INC. OBSTETRICAL KIT

Model Number	SINA214
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the report is not available for evaluation.Avid medical is a convenience kit manufacturer.The complaint component is (b)(6) hospital disposables part number 385 (registration number: 2433012).A supplier corrective action request was issued to the component manufacturer on (b)(6), 2024.Upon completion of the investigation, a follow-up report will be filed.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.H3 other text: device not returned.
Event or Problem Description
The customer reported umbilical cord clamp reopened after being clamped.This resulted in infant blood loss.Medical treatment was administered to stop bleeding.The infant is in good status, discharged from hospital.
Additional Manufacturer Narrative
The product involved in the report is not available for evaluation.The reported complaint has been evaluated and the investigation process has been completed.The investigation process included a thorough review of all production and quality inspection documents.These documents did not reveal any deviation from standard procedures established for the production of the kit reported or the inspection of the specific part with the issue.Furthermore, our current stock of umbilical cord clamps was re-inspected and found to be conforming.A subsequent production run of the same product was monitored closely, and no defects replicating the reported issue was identified.A review of rejection data showed no functional defects for this component.This is the first related complaint for the instrument.Despite our investigation not identifying a clear cause for the issue and finding no defects in the products, we believe this is an isolated issue.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly and quarterly.Our business team regularly reviews the collected data for identification of emerging trends.A root cause was not determined.This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or caused serious injury.H3 other text : device not returned.

• Brand Name: OBSTETRICAL KIT
• Common Device Name: OBSTETRICAL KIT
• Manufacturer (Section D): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer (Section G): AVID MEDICAL, INC.; 9000 westmont drive; toano VA 23168
• Manufacturer Contact: nichole early ; 9000 westmont drive; toano, VA 23168 ; 8287820529
• MDR Report Key: 19415615
• Report Number: 1047429-2024-00002
• Device Sequence Number: 3253429
• Product Code: OKV
• UDI-Device Identifier: 10809160411681
• UDI-Public: 10809160411681
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: SINA214
• Device Catalogue Number: SINA214
• Device Lot Number: 1597123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown