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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received indicating that a 16 french foley catheter (part 81-080416eu, lot 51342895) malfunctioned during use.Specifically, the balloon ruptured after placement.The product was placed october 5 and ruptured november 1.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 while placed in a patient.
Additional Manufacturer Narrative
Root cause: because a sample is unavailable for evaluation, a root cause could not be determined.Corrective action: due to the root cause, a corrective action has not been taken.Investigation summary: an internal complaint (call 51542) was received indicating that a 16 french foley catheter (part 81-080416eu, lot 51342895) malfunctioned during use.Specifically, the balloon ruptured after placement.The product was placed (b)(6) and ruptured (b)(6).An inventory check was completed (b)(6) 2020.The lot size was 300, and per ansi, 10 were verified.All samples checked were acceptable.The silicone catheter portion of the device is manufactured by spectrum plastics group.Therefore, a scar was issued to spectrum.A response was received (b)(6) and accepted by deroyal personnel.Spectrum reviewed its device history record for the lot number of the affected catheter and found no non-conformances.Each unit was 100 percent inspected during the process, and qc staff perform a functional device inspection prior to distribution.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 while placed in 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 37825
• MDR Report Key: 10930523
• Report Number: 2320762-2020-00004
• Device Sequence Number: 2478261
• 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): 01/28/2021

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: 51342895
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 01/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1