MAUDE Adverse Event Report: CONVATEC INC L3C0600 - CURE PRODUCTS; CATHETER, STRAIGHT

Model Number	510857
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer called in to report "a sharp edge" on the catheter.Consumer said "is typical cathing routine is washing his hands then checking his catheter by running his clean wet hand hand down the length of it to check it prior to placing lube and inserting.He said he recently found one of the m14c catheters that has a "strange sharp edge, about one and a quarter inches from the tip." he said "the flaw is right on the blue guide line." he said it "felt like someone glued a grain of sand on it".He was able to hold the catheter up to the light while we spoke and said he could see a little bump like a "micro bubble on the blue guide line." he said when he noted this prior to use, he did not use it concerned it would be very painful or "put me (him) in the hospital.".
Additional Manufacturer Narrative
Common device name: catheter, straight.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: (b)(4).Manufacturing site: (b)(4).
Additional Manufacturer Narrative
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.

• Brand Name: L3C0600 - 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: 14773495
• Report Number: 1049092-2022-00304
• Device Sequence Number: 6022083
• Product Code: EZD
• UDI-Device Identifier: 00815947020086
• UDI-Public: 00815947020086
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 06/15/2022

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: 05/28/2026
• Device Model Number: 510857
• Device Lot Number: 210610-1
• 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): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 11/04/2022
• Initial Report FDA Received Date: 06/22/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male