MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DOUBLE BASIN SET; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 89-8344

Device Problems Hole In Material (1293); Material Perforation (2205); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

Root cause: the sample was returned to deroyal for evaluation and the reported issue confirmed.Because the pack was removed from the sterilization process and used by the reporting customer, the true root cause cannot be determined.Corrective action: due to the investigation and root cause determination, a corrective action has not been taken.Investigation summary: an internal complaint (b)(4) was received indicating that a double basin set (finished good (b)(4)) contained a hole in the back table cover.The reporting customer filed two complaints ((b)(4)) for the same reported issue in the same finished good.An actual defective sample was returned for (b)(4), which is associated with this report.This defective sample consisted of a content sheet, back table cover, and a portion of the contents of the finished good kit.The product was removed from the sterilization pouch and subjected to the customer's set-up process.Due to the condition of this sample, the true root cause is unable to be determined.The work order was reviewed for discrepancies that would have contributed to the reported event.No discrepancies were identified.Deroyal will continue to monitor trends for this failure.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.

Event Description

Staff noticed holes in the drape.It is unknown when the holes were discovered.The drape was being used during a surgical procedure.

• Brand Name: DOUBLE BASIN SET
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avene; 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: 5967075
• MDR Text Key: 55274091
• Report Number: 3005011024-2016-00027
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8344
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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