MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC HYDRO-KIT; CATHETER, STRAIGHT

Model Number	42516
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The adverse event occurred outside us, in germany.A male patient has been using several urinary catheters, lofric hydro-kit tiemann (40cm, ch16).Lofric hydro-kit is a sterile, single use, hydrophilic catheter with salt solution for activation, intended for intermittent urinary catheterization.It has an integrated urine collection bag (primary package) and is ready to use anywhere.The wetting solution is used to activate the hydrophilic catheter coating before use.On (b)(6) 2025, the patient contacted the manufacturer representative and reported that there were holes in the weld seams of the urine collection bags for 10 of the products he had used.The defect in the urine collection bags was discovered during use and the urine leaked onto the patient instead of remaining in the urine collection bag.The patient reported that he found one hole in each urine collection bag.The patient was caused no harm.
Additional Manufacturer Narrative
The patient reported that there was a hole in the weld seam of the primary package, compromising the sterile barrier of the product.The patient had discarded all the 10 used products.No products from the affected lot were available to be returned to the manufacturer.The patient was caused no harm.Batch documentation has been reviewed and no earlier complaints are registered for this lot.Batch documentation refers to one deviation related to low temperature for welding tool for the primary packaging in the manufacturing.The deviation was handled and closed according to our procedures.To ensure that the weld strength was sufficient extended manufacturing controls were introduced over a period of time.No deviating values were obtained during the extended manufacturing controls.Since no failed products have been returned by the patient it is not possible to investigate this complaint further.And it is not possible to determine how the holes in the weld seams for the 10 concerned products occurred.The cause of this complaint has not been possible to establish.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.

• Brand Name: LOFRIC HYDRO-KIT
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, SE-43 121; SW SE-43 121
• Manufacturer Contact: anja bengtzelius ; aminogatan 1; p.o. box 14; mölndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 22343792
• Report Number: 3009632672-2025-00018
• Device Sequence Number: 8519520
• Product Code: EZD
• UDI-Device Identifier: 07333387042961
• UDI-Public: 07333387042961
• Combination Product (Y/N): N
• PMA/510(K) Number: K122078
• 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): 06/27/2025

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: 42516
• Device Catalogue Number: 42516003
• Device Lot Number: 657990
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/17/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Male