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

Model Number	HM14UK
Medical Device Problem Codes	Unsealed Device Packaging (1444); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: catheter, urological.Age: 81 years.Complainant email: (b)(6).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 "it looks like the way the catheter was sealed was misaligned and sealed too close to the catheter itself." end user's wife "thinks it is the heat from sealing that caused the catheter to stick to the packaging which she said is halfway at the bend in the catheter.Catheter is sticking before and after busting water sachet.She also said the seal misaligned is causing it to leak at bottom prior to opening packaging after bursting water sachet because it wasn't completely sealed at bottom/ tip end.She said it will leak out the bottom making a mess prior to opening packaging.She said it has been "hit or miss" in this box, some will stick and leak others will just stick and not leak or leak and not stick to packaging.Some are ok too.They are trying to remove them from packaging right after bursting water sachet as well after water has ran along all of catheter.They have been using the ones that they have been able to get unstuck.No different feel in urethra vs ones that do not have defect if they can get them unstuck/ no pain with use.No harm reported.".
Additional Manufacturer Narrative
The supplier used causality analysis during investigation.Finding are as below: 1.Photos of unqualified products are not provided, so they could not know the exact situation.They think there may be some wrinkles on the paper.After sealing with film, the edge wrinkle part is slight, the worker did not check it carefully, so the unqualified item was not picked out.Then, these unqualified items are send to customer.2.For ¿¿catheters stick to package¿¿ issue, they think there may be some workers handled catheters right after disinfected their hands.Their hands are not dry completely, so some part on catheters are damp because of hands and stick to package.Conclusion: this is human error.The supplier states the following retraining will be performed: 1.We will re-train workers who handle the hnc outer box packing and make sure they understand the checking requirements; re-train workers of the hnc blister packing line and make sure they understand the requirement.2.Re-train workers of hnc blister packing line, hand dry is requested after hand disinfection, so catheters will not be effected by the hand damp.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: CURE PRODUCTS
• Common Device Name: CATHETER, UROLOGICAL
• 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: 16639374
• Report Number: 1049092-2023-00035
• Device Sequence Number: 17501421
• Product Code: KOD
• UDI-Device Identifier: 00815947020505
• UDI-Public: 815947020505
• Combination Product (Y/N): N
• Initial Reporter State: SC
• PMA/510(K) Number: K080881
• 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): 03/15/2023

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 Expiration Date: 04/28/2025
• Device Model Number: HM14UK
• Device Lot Number: 22610003
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 03/29/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2022
• 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