MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L FOLEY CATHETER

Model Number	81-080414
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer sent a report regarding the medical device to the (b)(6), report number ((b)(6)).Evaluation of adverse event report determined that the medical device issues is not required to be reportable per the (b)(6).The device was not returned for evaluation; therefore we were not able to complete a thorough investigation.A supplier corrective action request (scar) has been sent to vendor in relation to the product issue; however, still waiting for completion.The investigation is incomplete at this time, a follow-up report will be submitted with additional information once received, this report will be updated.
Event or Problem Description
Foley catheter had slipped out and was draining onto the floor.Upon inspection of the balloon cuff, there was a 1-2 cm hole in the foley catheter balloon.
Additional Manufacturer Narrative
Scar investigation was completed by the supplier.Visual evaluation of the returned sample with a 1.5cm long cut on the balloon could be attributed to a sharp edge.No hole or pinhole was observed.In instance the balloon/catheter has come in contact with sharp edge.During inspection of inflation, balloon is checked by inflating and deflating before printing and inspecting temperature measurement.Balloon and catheter screening is completed twice.Batch review of in-process and final packaging inspections of manufacturing process with respect to production batch were reported to be in conformance with customer specifications, and have been found to be within all parameters.Review of device history record showed no discrepancies in processing of the work order of the finished good.Supplier root cause was not identified due the lack of evidence.Deroyal internal balloon testing was completed on 45 foley catheter samples of balloon testing.Results showed an average burst volume of 38.4cc, a safety factor of 7.6 times the specified fill volume of 5cc.Deroyal has sold 508 cases of finished good #81-080414 in the last two years with only one similar complaint involving a leakage from balloon.Deroyal will continue to monitor post-market feedback and will recognize any future trend development.The investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: FOLEY CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park, p.o. box 180-3006; 602 parkway, la aurora; heredia 146 ; CS 146
• MDR Report Key: 11821206
• Report Number: 2320762-2021-00002
• Device Sequence Number: 11650407
• Product Code: EZL
• UDI-Device Identifier: 00749756045773
• UDI-Public: 00749756045773
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K200757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 81-080414
• Device Lot Number: 51779966
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/30/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 07/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1