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

Model Number 81-080416EU

Device Problems Material Rupture (1546); Material Integrity Problem (2978)

Patient Problem Urinary Retention (2119)

Event Date 11/05/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (call#: (b)(4)) was received indicating a 16 french foley catheter (part#: 81-080416eu, lot#: 52048305) malfunctioned during use.Specifically, the balloon ruptured after placement.The catheter was placed on (b)(6) 2020, and ruptured (b)(6) 2020.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A 16 french foley catheter ruptured during use on a patient.

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 51544) was received indicating a 16 french foley catheter (part 81-080416eu, lot 52048305) malfunctioned during use.Specifically, the balloon ruptured after placement.The catheter 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 january 18 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 Description

A 16 french foley catheter ruptured during use on a patient.

• Brand Name: FOLEY CATHETER
• Type of Device: CATHETER, UPPER URINARY TRACT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1595 highway 33 south; new tazewell TN 37849
• MDR Report Key: 10930564
• MDR Text Key: 219361072
• Report Number: 2320762-2020-00006
• Device Sequence Number: 1
• Product Code: EYC
• UDI-Device Identifier: 00749756596664
• UDI-Public: 00749756596664
• Combination Product (y/n): N
• PMA/PMN Number: K041616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 81-080416EU
• Device Lot Number: 52048305
• Date Manufacturer Received: 11/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1