MAUDE Adverse Event Report: DEROYAL CIENTIFIC DE LATINOAMERICA S.R.L. FOLEY CATHETER, 400 SERIES 14 FR; CATHETER, UPPER URINARY TRACT

Model Number	BS81-080414
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received for a catheter that leaked from the balloon and slid out of the patient.The investigation is ongoing a this time.This report will be updated when new and critical information is received.
Event or Problem Description
Catheter was inserted into the patient.On inserting water into the retention balloon, the fluid was observed leaking from the urethral meatus and the catheter slid out.On testing after removal, the catheter was seen to have a leak in the balloon.10mls of water was used.It was not inserted into the catheter with any force, and there was no resistance.Procedure was delayed as another catheter had to be inserted to continue with the procedure.The catheter was being inserted into the patient to use as a temperature probe.
Additional Manufacturer Narrative
Root cause: the silicone catheter device component is supplied to deroyal by xeridiem.Therefore, a supplier corrective action request (scar) was issued to xeridiem.In its response, the supplier stated that a definitive root cause could not be determined due to the absence of a defective sample for evaluation.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint (call 50470) was received for a catheter (part bs81-080414) that leaked from the balloon and slid out of the patient.A sample was not returned for evaluation.However, photos of the defective device were provided.The work order for the affected lot was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.A scar and the photo were sent to xeridiem.A response was received august 24.Follow up was conducted and additional information was received from xeridiem on november 16.A total of 1,350 of reported lot has been sold.However, only 1 catheter from that lot was reported to have malfunctioned.A total of 19,750 cases of the finished good have been sold since july 2018.During this period, only one complaint was received for the finished good part.Deroyal will continue to monitor post-market feedback and will recognize int he future if a trend develops.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
Catheter was inserted into the patient.On inserting water into the retention balloon, the fluid was observed leaking from the urethral meatus and the catheter slid out.On testing after removal, the catheter was seen to have a leak in the balloon.10mls of water was used.It was not inserted into the catheter with any force, and there was no resistance.Procedure was delayed as another catheter had to be inserted to continue with the procedure.The catheter was being inserted into the patient to use as a temperature probe.

• Brand Name: FOLEY CATHETER, 400 SERIES 14 FR
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL CIENTIFIC DE LATINOAMERICA S.R.L.; box 180-3006, 602 parkway; la aurora; heredia, heredia 146 ; CS 146
• MDR Report Key: 10367699
• Report Number: 2320762-2020-00002
• Device Sequence Number: 19549511
• Product Code: EYC
• UDI-Device Identifier: 00749756045773
• UDI-Public: 00749756045773
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K041416
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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: BS81-080414
• Device Lot Number: 51021135
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 12/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1