MAUDE Adverse Event Report: CONVATEC INC Cure Catheter® Closed System; Tray, catheterization, sterile urethral, with or without catheter (kit)

Model Number	510800
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 2 of 3.Common device name: catheter, urological.Based on the available information, this event is deemed to be a reportable malfunction.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.(b)(4).
Event or Problem Description
End user's grandmother reports "she caths him 4 x a day as he was in an automobile accident resulting him quadriplegia and no feeling of his bladder and she caths him 4 x a day for retention.She reports for the cs12, the defect she reports is that the catheter tip is not in the blue guide part, it is floating in the bag making it unusable - she reports unknown qty of defected catheters, "maybe 1 or 2 a month for about the last 6 months" from unknown mu/s of unknown lots.Current mu box she just found qty 2 affected catheters is of lot # 220222-2.She states she discards them as they are unusable.She said she has noticed this start to occur only for about the last 6 months or so with maybe 1 or 2 a month she finds like this of these catheters.She said she cannot use as they are unusable as no way for her to get in his penis.She said she cannot make the catheter tip floating in bag go in the blue guide without opening the bag and she didn't think it would be good for her to open the bag and contaminate it because she knows it is sterile." she was advised to continue to "not use and she did the correct thing by not using catheters she finds like this.".

• Brand Name: Cure Catheter® Closed System
• Common Device Name: Tray, catheterization, sterile urethral, with or without catheter (kit)
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC ; 3365424679
• MDR Report Key: 15275773
• Report Number: 1049092-2022-00320
• Device Sequence Number: 7021297
• Product Code: FCM
• UDI-Device Identifier: 00815947020666
• UDI-Public: 00815947020666
• Combination Product (Y/N): N
• PMA/510(K) Number: K080881
• 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
• Report Date (Section B): 08/16/2022

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 Expiration Date: 09/28/2024
• Device Model Number: 510800
• Device Lot Number: 220222-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 08/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Male