MAUDE Adverse Event Report: CONVATEC INC CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	ULTRA M14C
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 1049092-2023-00160 / device 2 of 3.A2: sex: male d2a: common device name: catheter, straight e.1: complainant first name: (b)(6).Patient country: united states.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.Fda registration number reporting site: (b)(4).Manufacturing site: (b)(4).
Event or Problem Description
Consumer stated "he has used this catheter ever since he started to cath about 12-14 months ago.He caths 2 x day, morning and night for retention as his md explained it is like his "bladder collapsed." he said rarely in past, he has felt discomfort at tip of this catheter while passing through urethra but nothing that ever felt sharp like these that caused bleeding from this box which he suspected to be a defect.He said it was in new york recently for travel and he took some of his catheters with him.He said 3 felt very sharp at the very tips like they had extra plastic on the end that wasn't smoothed over.He "could not see the defect with his naked eye" at all but he said he felt it with use going in and it was at the the "very tip" of this catheter at the coude tip.He said he experienced bleeding with 2 out of the 3 that felt sharp.When he removed the catheter it was like he was "cut inside" and "blood squirted onto the floor" upon removal.He did say it stopped rather quickly without intervention, did not need to seek medical intervention.He is always mindful to keep the coude tip upwards when he passes this catheter.He does take clopidogrel 75mg daily as well a blood thinner.He said he used up the rest of the box and they worked ok, not sharp, however he as he has been opening up new boxes he has been "sandpapering the end of the catheters" now prior to use just in case." consumer was advised to not sandpapering the end as he is contaminating the catheter.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• 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: 16975710
• Report Number: 1049092-2023-00160
• Device Sequence Number: 11342291
• Product Code: EZD
• UDI-Device Identifier: 00815947021113
• UDI-Public: 00815947021113
• Combination Product (Y/N): N
• PMA/510(K) Number: K221593
• 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): 05/18/2023

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: 06/28/2025
• Device Model Number: ULTRA M14C
• Device Lot Number: 22B13703
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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: Unknown