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

Model Number	41012
Medical Device Problem Codes	Break (1069); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Adverse event occurred outside us, in italy.Lofric primo includes a wetting solution bag (sachet) that is used to activate the hydrophilic catheter coating before use.This is done by squeezing the integrated bag to release the wetting solution with the catheter in its package.When the patient squeezed the sachet to activate the coating of the catheter, the wetting solution came out from the side of the catheter package, indicating that the package's sterile barrier was compromised.This occurred with 60 catheters.The catheters were not used, and there was no harm or clinical impact on the user.The patient could perform the intermittent catheterization (ic) using products from another box.The patient has been catheterising with the same catheter for several years and has never experienced any problems before.
Additional Manufacturer Narrative
Batch documentation and production data have been reviewed and no relevant problems or deviations were registered.No earlier complaints registered for this lot.Review of batch documentation did not lead to any clear conclusion; therefore, no root cause could be established.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 PRIMO
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, 43121 ; SW 43121
• Manufacturer Contact: johanna lundqvist ; aminogatan 1; p.o. box 14; mölndal, 43121 ; SW 43121
• MDR Report Key: 20469259
• Report Number: 3009632672-2024-00016
• Device Sequence Number: 20700929
• Product Code: EZD
• UDI-Device Identifier: 07333387043005
• UDI-Public: 07333387043005
• 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): 10/17/2024

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
• Device Model Number: 41012
• Device Catalogue Number: 4101230
• Device Lot Number: 656025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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