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

Model Number	HM12
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reports "he has used this product for about 1.5 yrs and it worked well for him.He said he has had bleeding in the past before switching to cure with other brand catheters due to unpolished eyelets but said he has not had this issue with our cure hm12 until now with this new box he just opened.He has urinary retention due to a "very enlarged prostate", so large he said he is not a candidate for less invasive procedures and would need an invasive surgery which he does not want to do and has chosen to continue cathing 1 x per day and voids regularly the rest of the day.He said he was already told by his md he was "going to get some blood" every now and then with cathing.He said he does not take any medicines to shrink his prostate as he is concerned drugs' side effects.He said he has identified qty 5 catheters so far from this box (and he hasn't gone through them all or the other 2 new boxes he has of this product) that have rough eyelets.Two he used and 3 he has not used.He said he remembers them always having very polished rounded eyelets and never caused him an issue prior to this box but prior to this he never took a magnifying lens to them either in the past.He said these that had the unpolished eyelets that caused the bleeding didn't feel any different with use going through his urethra.He said the bleeding was light and it did stop quickly without intervention after use.He said by the time he woke up in am after cathing at his usual time of 4am, his urine was clear.He is not on blood thinners.He said this new bleeding with use sparked him to examine the catheters and that is when he found the defect.He said he took a magnifying lens to the two that caused the bleeding and he said they have "rough square edges" at the eyelets and described the eyelets as looking "ragged" that caused his bleeding.Now that he has identified this defect he has been checking the others in the box by looking at them (prior to use and prior to activation) with a magnifying lens though the packaging and identified 3 more than "look rough" at the eyelets and set those aside.He hasn't had bleeding in over as week and has only been using those catheters that have smooth eyelets." consumer was advised not to use any he identified as not having polished eyelets.
Additional Manufacturer Narrative
Initial 4 of 5.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: 1049092.Manufacturing site: 3005471919.
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Per supplier investigation, returned samples were received with no abnormality on the pouch.Tube was checked and confirmed the tip is smoothly closed.Magnifier also used to check and no burr or sharp edge was observed.10x magnifier was further used and some individual pieces have dentate protrusion, however this is not able to be detected by normal visual inspection or by finger.Another review was performed from another director and there was no burr or sharp edges, and feeling by fingers no sharpness was found.In summary, no burr or sharp edge both on returned samples and retention samples were observed.Eyelet quality may be one cause of bleeding but there are multiple factors as well, such as mucous membrane bleeding by friction.The actual piece that caused the bleeding was not provided.Awareness training of this issue was performed of workers at eyelet punching station and inspection station on the requirement of eyelet quality control.Should additional information become available, a follow-up report will be submitted.Fda registration number reporting site: 1049092.Manufacturing site: 3005471919.

• Brand Name: CURE PRODUCTS
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer (Section G): CONVATEC INC; 211 american avenue; greensboro NC 27409
• Manufacturer Contact: pamela meadows ; 7815 national service road; suite 600; greensboro, NC 27409 ; 3365424679
• MDR Report Key: 19152307
• Report Number: 1049092-2024-00043
• Device Sequence Number: 12870365
• Product Code: EZD
• UDI-Device Identifier: 00815947020307
• UDI-Public: 00815947020307
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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 Expiration Date: 05/28/2026
• Device Model Number: HM12
• Device Lot Number: 23B03201
• 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: 04/19/2024
• Supplement Date Received by Manufacturer: 07/04/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 81 YR
• Patient Sex: Male