MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. FOLEY CATHETER; CATHETER, UPPER URINARY TRACT

Model Number	81-080416EU
Medical Device Problem Codes	Material Rupture (1546); Material Integrity Problem (2978)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (call#: (b)(4)) was received indicating a 16 french foley catheter (part 81-080416eu, lot 47814407) malfunctioned during use.Specifically, the balloon ruptured after placement.The catheter was placed on (b)(6) 2020, and ruptured on (b)(6) 2020.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
A 16 french foley catheter ruptured during use on a patient.
Additional Manufacturer Narrative
Root cause: the root cause is undetermined.The supplier checked its batch history for the reported lot number and found no non-conformities.Corrective action: a corrective action has not been taken.Investigation summary: an internal complaint (call 51543) was received indicating a 16 french foley catheter (part 81-080416eu, lot 47814407) malfunctioned during use.Specifically, the balloon ruptured after placement.The catheter was placed (b)(6) and ruptured (b)(6).A sample was not returned for evaluation.Additionally, no information was provided as to where the catheter ruptured.Attempts were made to retrieve additional information from the initial reporter.However, the initial reporter was unable to provide any further information.The silicone catheter portion of the device is supplied to deroyal by degania.Degania reviewed its manufacturing process and final inspection reports for the reported lot.It found that the catheters underwent 100% inflation and deflation testing.No non-conformities were found, and all inspections were acceptable.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
A 16 french foley catheter ruptured during use on a patient.

• Brand Name: FOLEY CATHETER
• Common Device Name: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37849
• MDR Report Key: 10930498
• Report Number: 2320762-2020-00005
• Device Sequence Number: 16763702
• Product Code: EYC
• UDI-Device Identifier: 00749756596664
• UDI-Public: 00749756596664
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 01/07/2021

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: 81-080416EU
• Device Lot Number: 47814407
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1