MAUDE Adverse Event Report: WELLSPECT HEALTHCARE LOFRIC ELLE; CATHETER, STRAIGHT

Model Number	41812
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The adverse event occurred outside us, in great britain.On (b)(6) 2025, a femal patient contacted the manufacturer representative and reported a malfunction for the sterile, single-use, intermittent urinary catheter lofric elle (10cm, ch12).The patient reported that the catheter broke, the funnel which is glued to the catheter had come lose during use of the device.The patient was caused no harm.
Additional Manufacturer Narrative
Investigation is on-going.The manufacturer is waiting for products from the same lot as the affected device to be returned.
Event or Problem Description
The adverse event occurred outside us, in (b)(6).On (b)(6) 2025, a female patient contacted the manufacturer representative and reported a malfunction for the sterile, single-use, intermittent urinary catheter lofric elle (10cm, ch12).The patient reported that the catheter broke, the funnel which is glued to the catheter had come lose during use of the device.The patient was caused no harm.The used device was discarded by the patient.The patient further reported that she had opened a few more devices which also broke, but those devices were never used.The patient returned one of the broken devices and discarded the remaining.
Additional Manufacturer Narrative
Batch documentation and production data for the affected device have been reviewed and no relevant problems or deviations were registered on the released lot.Measurements from peak tensile force test, as part of the batch documentation, show results within specifications.No earlier complaints are registered for this lot.The used device was discarded by the user and not available to be returned to the manufacturer.The patient has returned 79 devices from the same lot as the used device.One of the returned devices had been opened by the user, it was broken and examination showed that the funnel had come loose from the tubing.The root cause has not been possible to establish.The remaining 78 unopened returned devices were also examined, and no more faulty devices were found.This is considered an isolated event, and no non-conformity or capa is opened at this moment, but the failure type will be closely monitored in our nonconformity system.For each lot also peek tensile force tests on 125 devices are performed.

• Brand Name: LOFRIC ELLE
• 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: 21924320
• Report Number: 3009632672-2025-00014
• Device Sequence Number: 4085459
• Product Code: EZD
• UDI-Device Identifier: 07333387024202
• UDI-Public: 07333387024202
• Combination Product (Y/N): N
• PMA/510(K) Number: K211212
• 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): 06/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 41812
• Device Catalogue Number: 4181225
• Device Lot Number: 664086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2025
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2025
• 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: Female