MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L. FOLEY CATHETER; CATHETER, UPPER URINARY TRACT

Model Number	81-080416
Medical Device Problem Codes	Obstruction of Flow (2423); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: the catheter portion of the device is supplied to deroyal by degania silicone.Therefore, a supplier corrective action request (scar) was issued to degania.In its response, degania stated a root cause could not be determined due to no sample being available for evaluation.No findings resulted from review of batch production documents.Corrective action: due to the root cause determination, a corrective action was not taken.Investigation summary: an internal complaint (call (b)(4)) was received for a foley catheter (part number 81-080416, lot 49982535) that was blocked and preventing urine from being drawn.A sample was not available for return.The silicone catheter portion of the device is supplied to deroyal by degania silicone.Therefore, a scar was issued to degania.A response was received october 10, 2019, and accepted by deroyal personnel.In its response, degania stated a sample was available for evaluation.Manufacturing records were reviewed and no non-conformities were identified.The affected batch passed 100 percent inspection.Additionally, a retained sample from the same batch was tested and functioned properly with no blockages observed.Deroyal has sold (b)(4) cases of the reported finished good from 2017 to present.During that time, two complaints have been received for this part, which equates to a complaint-to-sales ratio of 0.001.Deroyal will continue to monitor post-market feedback and will recognize in the future if a trend develops.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.
Event or Problem Description
Unable to draw urine from the catheter.The catheter looks like it is blocked.This occurred during use.

• Brand Name: FOLEY CATHETER
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L.; global park, box 180-3006; 602 parkway, la aurora; heredia, heredia 146 ; CS 146
• MDR Report Key: 9202211
• Report Number: 2320762-2019-00010
• Device Sequence Number: 16881627
• Product Code: EYC
• UDI-Device Identifier: 00749756045766
• UDI-Public: 00749756045766
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K041416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2019

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: Health Professional
• Device Model Number: 81-080416
• Device Lot Number: 49982535
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1