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

Model Number	41312
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device(s) was not available to be returned to the manufacturer for investigation.Since there were no lot number identified for the defective products manufacturer could not perform any investigation of the production batch records.Several attempts have been made to contact user for more information.A compromised sterile barrier means that the product does not fulfill the requirements for a sterile single use medical device.This malfunction was clearly visible for the user when the coating of the catheter with wetting solution was activated.Ifu state that products with broken or damaged sterile packaging should not be used.The welds of the product are inspected in the manufacturing process.5 samples are inspected at order start and after longer production stop or after adjustments/changes in the production that may have affected the sealing of the product.In final inspection of the product the welds are also inspected prior to release of the lot.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
An experienced user in italy have been using intermittent urology cathethers for several year.The affected product, 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.On august 2 the user discovered that the products primary package sterile barrier was compromised when the sachet was squeezed to activate the coating of the catheter and the wetting solution came out from the side of the catheter package.Same error was detected on 30 catheters which were discarded by the user.The catheters were not used, and there was no harm or clinical impact on the user.

• Brand Name: LOFRIC PRIMO
• Common Device Name: CATHETER, STRAIGHT
• Manufacturer (Section D): WELLSPECT HEALTHCARE; aminogatan 1; p.o.box 14; molndal, SE-43 121; SW SE-43121
• Manufacturer Contact: ulrika skogback ; aminogatan 1; p.o.box 14; molndal, SE-43-121 ; SW SE-43121
• MDR Report Key: 20331846
• Report Number: 3009632672-2024-00014
• Device Sequence Number: 15454723
• Product Code: EZD
• UDI-Device Identifier: 07333387043098
• UDI-Public: 07333387043098
• 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): 09/30/2024

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: 41312
• Device Catalogue Number: 4131230
• Device Lot Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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