MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. VENOUS PACK; GENERAL SURGERY TRAY

Model Number 89-8672

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/17/2017

Event Type  malfunction  

Manufacturer Narrative

Root cause: the debris has been identified as coming from two potential sources prior to and during the manufacturing process.These sources are vendor supplied products and during the manufacturing process.A review of the representative samples has identified the potential source of contamination as a stop sharp blank box (raw material (b)(4)).Corrective action: an engineering change order (b)(4) was implemented january 24, 2017, to add a glassine bag for the forceps and needle holder instruments in the finished good tray.Also, there will be a visual inspection on the sub-assembly prior to placing the components in the tray.Investigation summary an internal complaint (b)(4) was received indicating there was debris inside a sterile finished good pack (part number 89-8672).A representative sample was returned for evaluation.This revealed there was a black speck on the foam block inside of the tray and a hair on the outside of a ziplock bag that these sample items were in for evaluation.Deroyal does not place this ziplock bag into the tray.The initial review has indicated potential sources of the black debris as the following: the forceps or needle holder which are placed into the 16-ounce bowl or the stop sharp blank box that is placed into the tray.Since january 24, 2017, the forceps and needle holder are packaged in a glassine bag prior to placement in the 16-ounce bowl.The work order was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.This work order was built on december 1, 2016, prior to implementation of an eco to place the instruments into a glassine bag.Due to the complaint investigator identifying the stop sharp blank box as a potential source of contamination, a supplier corrective action request has been issued to aspen surgical products, which supplies the component.As of the date of this report, a response has not been received.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.

Event Description

A sterile venous pack tray was opened bedside in the er to perform a vascath placement.There was black debris on the inside of the sterile pack drape.The instruments and syringes were loose in the sterile pack.

• Brand Name: VENOUS PACK
• Type of Device: GENERAL SURGERY TRAY
• 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: 6536439
• MDR Text Key: 74180487
• Report Number: 3005011024-2017-00006
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-8672
• Device Lot Number: 4785427995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• 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