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

Model Number	41012
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Batch documentation for the affected device has been reviewed and no relevant problems or deviations were registered.No earlier complaints are registered for this lot.Review of batch documentation did not lead to any clear conclusion, therefor the root cause could not 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.
Event or Problem Description
The adverse event occurred outside us, in (b)(6).The device 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 user 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.The catheters were not used, and there was no harm or clinical impact on the user.

• Brand Name: LOFRIC PRIMO
• Common Device Name: CATHETER, STRAIGH
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o. box 14; mölndal, SE-43 121; SW SE-43121
• Manufacturer Contact: anja bengtzelius ; aminogatan 1; p.o. box 14; mölndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 20579971
• Report Number: 3009632672-2024-00017
• Device Sequence Number: 8575447
• 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): 10/30/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: 41012
• Device Catalogue Number: 4101200
• Device Lot Number: 657398
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/04/2024
• 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: Unknown