MAUDE Adverse Event Report: UNOMEDICAL S.R.O. CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	M12
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number, reporting site: 1049092 , manufacturing site: 3005471919.
Event or Problem Description
End user reports catheter breaking apart (with use) in his urethra.End user reports using needle nose pliers to pull catheters out of his urethra.He reports that 5 total have broken off and "i have had to manipulate the broken part up the urethra far enough to grab them with needle nose pliers to remove them".End user reports that there were 5 catheters that broke 3-4 " up from the eyelets.He says on inspection he noticed a white mark in the catheter like it had been bent and the plastic was weakened.He is using a 12fr straight catheter.He reports bleeding for 4 days, is on antibiotics and is dripping blood in between catheterization as well.He caths 7-10 x per day.He has terminal asbestos cancer that is in his kidneys, bladder lungs etc.Additionally, end user reports bleeding from his urethra prior to this traumatic event due to his terminal diagnosis but this event did cause trauma and more bleeding.
Additional Manufacturer Narrative
Investigation report was completed by supplier cure (integral) and root cause is not identified.Retention samples were reviewed, and no defect was found on the pouch.Further inspection was done to the tube and no similar defect was found.¿based on the investigation, it¿s believed there is no step during manufacturing and inspection process to cause such defect.Due to no details on using process, and no photo for the broken tube, we cannot take out further investigation.Root cause is not identified.¿.Should additional information become available, a follow-up report will be submitted.Fda registration number : reporting site: 1049092.Manufacturing site: 3005471919.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer (Section G): UNOMEDICAL S.R.O.; priemyselny park 3,; michalovce 07101 ; LO 07101
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 19201337
• Report Number: 1049092-2024-00047
• Device Sequence Number: 20815163
• Product Code: EZD
• UDI-Device Identifier: 00815947020024
• UDI-Public: 00815947020024
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2024

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: Lay User/Patient
• Device Model Number: M12
• Device Lot Number: 22B17901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 04/29/2024
• Supplement Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male