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

Model Number	F14NC
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Event or Problem Description
End user reports recurrent utis for last 3 months with use of f14nc catheters.She said "she really isn't sure why she has been getting so many utis all of a sudden these last 3 months.She has been using these catheters for many years during her 15 years cathing and didn't get utis prior with use of these.She caths 6 x a day following nerve damage to her bladder following a tumor that was removed from her spine.She said she did have kidney stones during these last 3 months she got surgically taken care of and she thought that was to blame for her utis as she knows stones will place her at risk for utis.She said she has to follow up with her urologist to follow up post surgically as she was recently x-rayed to ensure all stones gone.She said she hasn't had typical uti symptoms and denies all other uti symptoms with her only symptom is having a "draggy feeling" and just doesn't "feel well" so she calls her urologist and they have her do a urine sample and they have her treated with antibiotics based on urine results showing utis.She mentioned she has had amoxicillin, bactrim rounds during last 3 months she has had and she is currently taking a treatment round of bactrim since last thursday for her latest uti.She said she goes for urine testing after her antibiotic rounds and she said her urine looks like there is no uti per her urologist then 1 or 2 weeks goes by and she gets another one.She said this most recent uti she is being treated for was right after she went home from the hospital as she recently had shoulder surgery.She said she was tested prior to going into the hospital and she had no uti.When asked if they had placed a foley catheter in her for the surgery she said she didn't remember one.She thought "maybe the material has got something to do with it" clarified with her possible concern of the material's sterility.She confirmed with me they were all packaged with intact packaging prior to use.Nothing abnormal about these catheters.No pain or discomfort with use as well.She washes her hands prior to cathing, she makes sure catheter stays sterile prior to insertion and only holds the very end of it.She said she also wipes her urethra with an antibacterial wipe prior to insertion.She never has used lubricant with these catheters stating she "was never instructed to." end user was advised her we do advise to use lube with uncoated catheters.
Additional Manufacturer Narrative
Common device name: catheter, straight.Based on the available information, this event is deemed to be a serious injury.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).

• 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: 15827623
• Report Number: 1049092-2022-00417
• Device Sequence Number: 6222989
• Product Code: EZD
• UDI-Device Identifier: 00815947020246
• UDI-Public: 00815947020246
• Combination Product (Y/N): N
• PMA/510(K) Number: K072539
• 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): 11/04/2022

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 Expiration Date: 02/01/2026
• Device Model Number: F14NC
• Device Lot Number: 210322-3
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 11/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2021
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Female