MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC HYDRO-KIT; LOFRIC HYDRO-KIT NELATON 40CM CH18

Model Number	42018
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported issue concerned a perforation located at the lower part of the urine collection bag, which resulted in urine leakage onto the patient and the surrounding environment.No medical complications or adverse health effects were reported by the patient.However, a puncture urine collection bag represents a compromised sterile barrier, which introduces a potential risk of contamination.Such contamination may increase the risk of developing a urinary tract infection (uti), although no infection was reported in this case.The used products were discarded at the point of care, and no samples were returned to the manufacturer for investigation.Batch documentation for this product did not show of any relevant problems or deviations.Based on the information available, our assessment identifies two plausible points within the manufacturing process where this type of defect could occur: improper positioning of the product on the carrier during transfer between production steps, or insufficient weld integrity along the weld seal lines (wcl), potentially caused by temperature variations during the welding process.However, as no defective products were returned for examination, it is not possible to confirm a definitive root cause.Should additional facts prompt us to alter or supplement any information of conclusions contained in this report, a follow-up report will be submitted.
Event or Problem Description
Adverse event occurred outside us, in france, where a male user reported that the lofric hydro-kit urine collection bag was punctured, resulting in urine leakage during use.The leakage occurred each time the product was used, with the defect located in the lower part of the bag.The user experienced discomfort and an unpleasant situation as he became wet with urine during catheterization.No medical complications or adverse health effects were reported.According to the information received, a total of three (3) products were affected.All three (3) used products were discarded and therefore not available for investigation.Lofric hydro-kit is a sterile single use urinary catheter.Each primary sterile package consists of a catheter, a water sachet (wetting solution bag) and a urine collection bag.The wetting solution bag is used to activate the hydrophilic catheter coating before use.

• Brand Name: LOFRIC HYDRO-KIT
• Common Device Name: LOFRIC HYDRO-KIT NELATON 40CM CH18
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; mölndal, SE-43 121; SW SE-43121
• Manufacturer Contact: ulrika skogbäck ; aminogatan 1; p.o.box 14; mölndal, SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 24556964
• Report Number: 3009632672-2026-00007
• Device Sequence Number: 15686587
• Product Code: EZD
• UDI-Device Identifier: 07333387042848
• UDI-Public: 07333387042848
• 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): 03/10/2026

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: 42018
• Device Catalogue Number: 42018703
• Device Lot Number: 668904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/28/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male