MAUDE Adverse Event Report: OASIS MEDIKAL GENTLECATH HYDROPHILIC; GENTLECATH URINARY CATHETER WI

Model Number	622PM401640
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Quality samples from the same lot was examined, no sharp edges was identified nor modification to the manufacturing process which was implemented.No deviations were found when the batch documentation was reviewed.No relevant deviations or earlier complaints were found for this lot.The product was not available to be returned.Without the benefit of examination and testing, wellspect healthcare is precluded from commenting on the condition of the device or the cause of the occurrence.Should the device or additional information be received, a follow up report will be filed.
Event or Problem Description
According to the patient, some catheters have rough eyelets and sharp edges.The patient claims the mechanism with how the eyelets are being punched out in manufacturing is not working correctly and eyelets are not being polished well.The catheters with sharp edges have caused bleeding in him as they pass through his prostate, but bleeding typically stops quickly without intervention, and at his next catheterization (after 3-4 hours) the bleeding is gone.He is not on blood thinners and did not seek medical care for his bleeding.

• Brand Name: GENTLECATH HYDROPHILIC
• Common Device Name: GENTLECATH URINARY CATHETER WI
• Manufacturer (Section D): OASIS MEDIKAL; fatih mah. 3105.; cad. no:8 06980; kazan/ankara, kazan/ankara ; TU
• Manufacturer (Section G): OASIS MEDIKAL; fatih mah. 3105.; cad. no:8 06980; kazan/ankara, ; TU
• Manufacturer Contact: emad ramzi ; aminogatan 1; se-43121 mölndal, mölndal ; SW
• MDR Report Key: 19151269
• Report Number: 3006553489-2024-00001
• Device Sequence Number: 8446096
• Product Code: EZD
• UDI-Device Identifier: 00768455142620
• UDI-Public: 00768455142620
• Combination Product (Y/N): N
• PMA/510(K) Number: K062444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2024

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: Lay User/Patient
• Device Model Number: 622PM401640
• Device Catalogue Number: 622PM401640
• Device Lot Number: 642314
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White