MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. C-SECTION PACK; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number 89-9416

Device Problems Contamination (1120); Device Contamination with Body Fluid (2317); Contamination /Decontamination Problem (2895)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2020

Event Type  malfunction  

Manufacturer Narrative

Root cause: the sample was not returned for evaluation because it was discarded.Therefore, a true root cause is unable to be determined.However, a potential root cause has been identified.Specifically, a one-time change order was completed to swap gown components in the convenience kit.Corrective action: a corrective action has not been taken due to the root cause determination.Investigation summary: an internal complaint (call 50334) was received indicating that a surgical gown contained in a c-section kit (finished good 89-9416) was not impermeable and allowed fluid to soak through the gown.The sample was not available as it had been discarded.Initially, a lot number of 562175574 was reported.However, this is incorrect.The correct lot number was identified as 52175574.The work order was reviewed for discrepancies that may have contributed to the reported issue.During this review, it was identified that a one-time change order was completed for the reported lot.Specifically, one gown part was removed and replaced with the gown involved in the reported incident.This was done at the sales representative's request.This gown was only used for the one-time change order and is no longer included in the convenience kit.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

After a scheduled cesarean section case, the physician scrub was soaked/soiled with body fluid.The surgical gowns are normally impermeable.

• Brand Name: C-SECTION PACK
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette, tn
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette, tn
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, tn ; 3626112
• MDR Report Key: 10279515
• MDR Text Key: 200468429
• Report Number: 3005011024-2020-00003
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-9416
• Device Lot Number: 52175574
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2020
• 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