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

Model Number	HM14C
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 13 of 15.Common device name: catheter, straight.Procode: ezd.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 reports the catheters "are already sticking in the packaging nearly "50% bonded to package" even before activation he does not use them.He said even after activation these will "rip paper fiber" when he goes to remove them.His concern is also that these catheters have a "sharp edge" once unglued to packaging on that area that was stuck along with paper fibers.He also notes that the area near the tip is uncomfortable as the coating after activation can look like "lumps, chunks, grains of sugar" which makes the tip uncomfortable if used.He said he has used 10 x magnification and he said he thinks it's because the hydrophilic coating is initially placed unevenly.He said he knows it's the coating as he has let them dry just to observe them and does not use them and he said these lumps disappear and dry out.Last week he did end up using one that was stuck to packaging and he said he "regrets it".He started to feel sharp pain with insertion as the coating created a sharp edge to the catheter.Pain went away after use, no interventions needed." a separate case has been created for the "rip paper fiber".

• 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: 15986289
• Report Number: 1049092-2022-00544
• Device Sequence Number: 17668101
• Product Code: EZD
• UDI-Device Identifier: 20815947020349
• UDI-Public: 00815947020345
• Combination Product (Y/N): N
• Initial Reporter State: PA
• PMA/510(K) Number: K132500
• 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
• Report Date (Section B): 12/09/2022

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: 04/28/2025
• Device Model Number: HM14C
• Device Lot Number: 220528-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/09/2022
• Initial Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2022
• 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 Age: 67
• Patient Sex: Male