MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. GENERAL SURGERY PACK; KIT, SURGICAL, INSTRUMENT, DISPOSABLE

Catalog Number 89-7012

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: call (b)(4) was received indicating that finished good 89-7012, general surgery pack, lot number 39565826, contained a lap sponge contaminated with an insect.The qc complaint specialist reviewed the work order for discrepancies that would have contributed to the reported issue.No discrepancies were identified.Lot mapping identified that finished good 89-7012, lot number 39565826, contained raw material (b)(4), lot number 21nh12.(b)(4) supplied the raw material lot number.The 2013-2015 supplier corrective action request (scar) and supplier notification letter (snl) logs were evaluated for similar complaints.Similar complaints were identified for contamination of a lap sponge.(b)(4) was issued and due 9/1/2015.The qc complaint specialist contacted (b)(4) in reference to the scar on the following dates: (b)(6) 2015.(b)(4) requested additional time to complete the scar response.The deroyal supply chain department was included in communication with the vendor for awareness of the report.Refer to the call (b)(4) email communication.(b)(4) responded to the scar on (b)(4) 2015.Refer to the (b)(4) response.The sample was received and evaluated, but the source of the insect could not be determined.The 21 cfr requires each manufacturer to establish and maintain procedures to prevent contamination of equipment or product by substances that reasonably could be expected to adversely affect product quality.The clean manufacturing area is monitored to minimize bug contamination.Although these processes cannot totally be controlled, there are steps which can be taken to maximize their effects.To assist in preventing the issue from occurring, the lafollette tray division complies with deroyal corp.(b)(4), pest control procedure, by having a pest control company conduct monthly pest control.This reduces the likelihood of pests entering the facility and work areas.The qc supervisor of the manufacturing facility reviewed the pest control documentation.The facility is up to date on pest control and no lapse in service has occurred.Refer to the branch plant 20 pest control documentation attachment.Correction: a credit has been provided.Root cause analysis: the true root cause of the insect contamination has not been identified.Insect contamination has been identified as coming from two potential sources.The first source was identified as being introduced into the manufacturing facility/products via vendor supplied products.A scar was issued to address the potential source of a vendor supplied item.Scar: the lot was manufactured in the summer.The insect might have gone into the finished product warehouse while one of the packages/cartons was not properly sealed.The second source was identified as the manufacturing facility.Possible root causes have been identified as the following: insects and their invasive behavior during times of excessive cold or hot weather conditions; all potential access points have not been identified; dock doors are open during delivery and/or shipment periods; employees entering and exiting the building; and pests can enter in the manufacturing area via employee clothing.Corrective action and/or systemic correction action taken: scar: increase inspection of the final package/carton.Deroyal: due to the investigation and root cause determination, a corrective action has not been taken.Preventive action: scar: implement more insect controls at the finished product warehouse.Deroyal: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete at this time.This report will be updated if new information becomes available.

Event Description

The pack was identified to have an insect embedded within the lap sponges.The operating room suite was considered contaminated and caused a 20 minute procedural delay.There was no patient harm.

• Brand Name: GENERAL SURGERY PACK
• Type of Device: KIT, SURGICAL, INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central ave; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central ave; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5065011
• MDR Text Key: 25355123
• Report Number: 3005011024-2015-00007
• 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: Other
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-7012
• Device Lot Number: 39565826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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