MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC HYDRO-KIT; LOFRIC HYDRO-KIT NELATON MALE 40CM CH12

Model Number	42012
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The adverse event occurred outside us, in cyprus.A male patient has been using, a sterile, single-use intermittent urinary catheter lofric hydro-kit (40cm, ch12).On march 24th, 2026, the patient contacted the manufacturer representative and reported that he had received three products where the primary package was not sealed completely, it had a hole and was leaking.Since the primary package is the sterile barrier of the product, a hole in the primary package is compromising the sterile barrier of the product.The patient reported that he had used the products and that he had discarded them after use.The patient did not suffer any harm.
Additional Manufacturer Narrative
Batch documentation has been reviewed, and no deviations or earlier complaints are registered for this lot.The patient reported that he had received three products where the primary package was not sealed completely it had a hole and was leaking, compromising the sterile barrier of the product.The products had been discarded by the patient after use, but the patient could provide photos.It was clearly visible in the photos that the primary packaging weld is too narrow on certain parts of the packaging.This lot has been produced in accordance with our procedures.To secure the welds of the products, in the production at wellspect healthcare, 4 products are inspected visually at the start of each order, after adjustments and once every hour.Impenetrability test of urinary bags of 4 products are performed at start of each lot and after adjustments.Nothing deviating was found in the production controls of this lot.The root cause of this incident has not been possible to establish.The process is validated with documented capability.Scheduled sampling inspections are used as a monitoring activity to detect deviations.The risk of low-frequency short-term failures passing is assessed as acceptable based on risk analysis and regulatory requirements.100% control would not provide a significant risk reduction compared to the current strategy.

• Brand Name: LOFRIC HYDRO-KIT
• Common Device Name: LOFRIC HYDRO-KIT NELATON MALE 40CM CH12
• 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-43 121
• MDR Report Key: 24940048
• Report Number: 3009632672-2026-00016
• Device Sequence Number: 8946873
• Product Code: EZD
• UDI-Device Identifier: 07333387042817
• UDI-Public: 07333387042817
• 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): 04/21/2026

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: 42012
• Device Catalogue Number: 42012003
• Device Lot Number: 674742
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/20/2025
• 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