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

Model Number	F14
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
End user reports one f14 catheter with a deformed sharp edged tip.End user states she has been using these "for years, 6x a day, to empty her bladder due to her bladder's inability to empty.She said this catheter has always been great for her.She said this must be "one in a million" defects as all the years she has used this she has never had this occur.She said she only found 1 from a box she used up that had this defect where the tip was not rounded as usual but rather looked cut off." she said "it looks like someone cut off the end with a knife." she said she usually never looks at them prior to use and when she tried to insert it, it did "hurt a little" as the ends felt sharp so she did not proceed to insert.She removed it and looked at it and noted this defect and did not continue to use.She said she has "no damage" to herself from having attempted use of this.She said she typically will try and void first to wet her urethra then does place lubricant on her catheter prior to insertion.She normally doesn't inspect them prior to use as she is so used to cathing." end user was advised to look at her catheters prior to use just to makes no defects are found and if so to not use and report to us.
Additional Manufacturer Narrative
A2: sex: female, age: 79.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.

• 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: 17255695
• Report Number: 1049092-2023-00213
• Device Sequence Number: 5773869
• Product Code: EZD
• UDI-Device Identifier: 00815947020215
• UDI-Public: 00815947020215
• Combination Product (Y/N): N
• 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): 06/29/2023

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 Model Number: F14
• Device Lot Number: 220310-2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 07/05/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown