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

Model Number	HM14C
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E.1: complainant street address: (b)(6) based on the available information, this event is deemed to be a serious injury.This complaint has been evaluated.No lot number is available.A detailed investigation or batch review cannot be conducted.Therefore, this evaluation will be closed.This issue will be monitored through the post market product monitoring review process.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 reported bleeding and urosepsis when using the hm14c catheter.The end user "caths 8 - 10 times a day.He has cathed for 23 yrs and primarily used the striaght tip hm14 catheter and it has always worked very well for him.He said he doesn't get utis often, maybe will get the average 1- 2 utis per year." he said he was recently taking antibiotics for a previously diagnosed uti and then he received his order from his supplier and "at first he did not notice but they had accidentally given him a different catheter than what he was used to.He is always used to using the hm14 however he was sent the hm14c in error by supplier.For that prior uti he was being treated for with antibiotics, he was not blaming his regular hm14 saying he was recently traveling and during the plane ride couldn't cath as often as he is used to.He often gets constipation as well and has not been able to afford his medication to help this." his hygiene routine was reviewed and he is always good about washing his hands, cleansing his glans prior to insertion and uses the no touch sleeve and careful to not contaminate catheter prior to use." he said he used about qty 5 or 6 of the new shipment he received from his supplier, which was the hm14c and again, but he "had no idea they were initially different at first so he knows he did not know to place them in with curve tip upwards and he ended up cutting himself and bleeding which quickly turned into urosepsis.At the time this occurred he was only partially through that antibiotic course he was initially placed on for his prior uti.He said his blood pressure went very low and he was admitted in the icu for 3.5 days on iv antibiotics and now is on his first week of his 4 weeks of oral antibiotics he was sent home on from icu and is feeling much better.He is not blaming the hm14c catheter itself just the fact that it was sent to him in error as he has never used coude tip catheters and that is not his prescription as he has always used straight tips.He said since he came home from the hospital he has had to reuse catheters at times because he only has very few that are his usual straight tips and is awaiting more from supplier." he was advised not to reuse catheters.".

• Brand Name: CURE CATHETER
• 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: 22467374
• Report Number: 1049092-2025-00205
• Device Sequence Number: 14521030
• Product Code: EZD
• UDI-Device Identifier: 00815947020345
• UDI-Public: 00815947020345
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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
• Report Date (Section B): 07/07/2025

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: HM14C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 60 YR
• Patient Sex: Male