MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH® II; NTRODUCER, CATHETER

Model Number	SS6
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We have been having some issues with the valves on the safe sheaths.When peeled the valve doesn't split and needs to be cut.Product was not kept by facility.
Additional Manufacturer Narrative
No product was returned to oscor inc.For evaluation; however, a complaint notification was provided.The customer stated the facility did not keep the product; therefore, does not have the product to return.Multiple attempts were made to confirm the product disposition.Without the return of the actual device in question for evaluation, oscor inc.Is unable to determine the exact cause for this incident; however, the customer did provide an image of the device which appears to show the reported issue; however, the device cannot be tested.As per the event description, when peeled the valve doesn't split and needs to be cut.The device history records were reviewed to confirm that the device passed all applicable in-process and final inspections.At this time, it is not possible to assign a definitive root cause for the event as reported.The complaint is non-verifiable as the product was not returned for evaluation.Oscor inc.Is submitting the above report to comply with 21 cfr part 803, the medical device reporting regulation.The report is based upon information obtained by oscor inc.Which the company may not have been able to investigate or verify prior to the date the report was required by fda.This report does not constitute an admission that the device, oscor inc., or its employees, caused or contributed to the event described in this report.Nor does this report reflect a conclusion by fda, oscor inc., or its employees, that the report constitutes an admission that the device, oscor inc., or its employees caused or contributed to the event described in this report.

• Brand Name: SAFESHEATH® II
• Common Device Name: NTRODUCER, CATHETER
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor 34683
• Manufacturer Contact: ronnie greco ; 3816 desoto blvd.; palm harbor 34683 ; 7279372511
• MDR Report Key: 19923593
• Report Number: 1035166-2024-00087
• Device Sequence Number: 15472475
• Product Code: DYB
• UDI-Device Identifier: 30891492002211
• UDI-Public: 30891492002211
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K122084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2024

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: SS6
• Device Catalogue Number: SS6
• Device Lot Number: DP20522
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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