MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ABSCESS DRAINAGE SYSTEM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 77-300726

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause: the true root cause of the reported issue is unable to be determined due to the lack of lot information and a sample for evaluation.A possible root cause of assembly error has been identified.Corrective action: the process manager and angio employees have been made aware of the reported incident.Investigation summary an internal complaint ((b)(4)) was received indicating that, during use of an abscess drainage kit (part 77-300726), a stopcock became plugged allowing for abscessed fluid to spray out of the line and onto the floor.The customer did not provide a lot number in its initial report.Additionally, the customer indicated a sample was unavailable for evaluation because staff had discarded it prior to reporting the incident.Deroyal personnel followed up to obtain a lot number, but a lot number could not be provided due to the defective product being discarded.Without a lot number or a sample for evaluation, a true root cause cannot be determined.The bill of materials and schematic for the finished good were reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.The reported finished good number has not been built since june 2013.Between 2013 to 2015, deroyal has sold (b)(4) cases of the product.There have been no similar reports.Preventive action: due to the root cause determination, a preventive action has not been taken.Note: this report has not been filed within the 30 days required by regulation.The report was not filed for review by regulatory affairs upon initial receipt of this complaint in accordance with internal complaint handling procedure.This is due to an isolated error by quality assurance and retraining according to procedure requirements has been completed with necessary employees.The quality assurance group manager has reviewed all complaints for the last 3 months to ensure all necessary complaints have been flagged for review by regulatory affairs.The investigation is complete at this time.This report will be updated upon completion of the capa.The investigation is complete at this time.If new and critical information is received, then this report will be updated.

Event Description

The line from the stopcock to the drainage bag became plugged and then the abscessed fluid sprayed out of the line onto the floor/room.This caused a minimal 5-10 minute delay because the staff needed to hook the line back in and hold it as the clinician finished the procedure.It added more time in needing to get the room cleaned and sanitized.

• Brand Name: ABSCESS DRAINAGE SYSTEM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 6439858
• MDR Text Key: 71054390
• Report Number: 3005011024-2017-00005
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935985
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 03/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 77-300726
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1