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

Model Number	M14
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported the "package not sealed properly.".
Additional Manufacturer Narrative
The emdr with manufacturer report number mdr 1049092-2024-00114, submitted on 09/23/2024 was submitted in error as this case was determined to be not reportable based on additional information received.Please retract the report.
Event or Problem Description
Additional information was received that stated the end user was misusing the product.No actual product malfunction occurred.

• Brand Name: CURE PRODUCTS
• 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: 20278383
• Report Number: 1049092-2024-00114
• Device Sequence Number: 15450486
• Product Code: EZD
• UDI-Device Identifier: 00815947020031
• UDI-Public: 00815947020031
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 09/16/2024

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: M14
• Device Lot Number: 23B00202
• 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): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2024
• Supplement Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2023
• 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