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

Model Number	M14
Medical Device Problem Code	Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reports "he has noticed in his most recent box of m14 catheters the paper is ripping unevenly in about qty 4 in his most recent mu box, lot unknown.Consumer wanted to remain anonymous to submit this complaint, no further contact info able to be obtained other than his phone number.He is not new to cathing and state he is paraplegic.He said he used to use the m14 in the past but never had issues with paper packaging tearing unevenly like now." recently, he ordered more m14s and he said in his newest box of m14 the paper tears unevenly about 1/3rd to 1/2 way down the catheter.The paper sides are sticking and not lifting and he is only left with the unevenly torn paper in his hand.He said of the first 4 he used in this new box they all tore this way and finally at his 5th one he said it tore well evenly.He thinks maybe they were glued to tightly he is not sure.He said he always rips the packaging from right to left horizontally.He said he did not use catheters that ripped unevenly as he didn't want the invisible "paper particles" to get on catheter contaminating it or risk of catheter touching outside unevenly ripped packaging upon removal putting him at risk for uti." no harm was reported.
Additional Manufacturer Narrative
Device 1 of 4.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: 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: 16639282
• Report Number: 1049092-2023-00037
• Device Sequence Number: 6642418
• Product Code: EZD
• UDI-Device Identifier: 00815947020031
• UDI-Public: 00815947020031
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/17/2023

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: M14
• Device Lot Number: 22B08301
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/29/2023
• 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 Sex: Male