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	08/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reviewed image sent with the complaint shows that the funnel has not been mounted correctly on the tube.Two complaints were registered previously to this one, regarding the same problem (catheter detaching from funnel).These complaints were from uk and sweden.Batch documentation and production data have been reviewed and no relevant problems or deviations were registered.Examination of the returned product samples (150) shos no defects or deviations.Measurements from the supplier's peak tensile force test show results within specifications for sample from the same raw catheter lot 740625.Contact with the supplier of the raw catheter, showed there is an open non-conformity on the same issue.This was identified in wellspect's production in june, for raw catheter lot 760787.Investigation by the supplier concluded that a limited number of catheters were incorrectly assembled in this specific lot.The manufacturer of the equipment has been on site and adjusted the glue application, and the glue-related issues decreased afterwards.More controls of the defect products will be performed, and further investigation will take place.In order to decrease the risk of incorrectly assembled products reaching customers, the supplier would like to install a sensor to measure the length of the catheters inline and they will get back to us when they have found an appropriate solution for this.A supplier deviation report (sdr) has been opened, and all three complaints were manufactured before the sdr was initiated.Referencing to the above investigation by the supplier we agree that this is a plausible root cause for the described product problem.We will continue to monitor the suppliers suggested improvements closely.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 uk.A 58-year old female patient with a history of neurogenic bladder and interstitial cystitis reported a malfunction for a sterile, single-use, intermittent urinary catheter lofric elle.The catheter was inserted as normal but upon withdrawal the catheter broke.The catheter tube came off the handle and was left inside the patient's urethra.Patient manage to retrieve the catheter tube.There was no harm or health impact to the patient.Patient hasn't had any problems with any other catheters in the same lot but decided to return the rest of the products in this lot in case more are affected.

• Brand Name: LOFRIC ELLE
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; mölndal, SE-43 1 21; SW SE-431 21
• Manufacturer Contact: ulrika skogbäck ; aminogatan 1; p.o.box 14; molndal SE-43-1 21 ; SW SE-431 21
• MDR Report Key: 22951091
• Report Number: 3009632672-2025-00028
• Device Sequence Number: 15554697
• 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
• Report Date (Section B): 09/03/2025

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: 666741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 03/27/2025
• 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 Age: 58 YR
• Patient Sex: Female