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U.S. Department of Health and Human Services

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

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DEROYAL INDUSTRIES, INC. SURE PACK GENERAL SURGERY TRAY Back to Search Results
Model Number 89-7577
Device Problems Material Separation (1562); Material Integrity Problem (2978)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2019
Event Type  Malfunction  
Manufacturer Narrative

Root cause: the gauze contained within the convenience kit is supplied to deroyal by (b)(4) a supplier corrective action request (scar) was sent to (b)(4) as well as pictures of the reported event. In its response, (b)(4) stated the photo showed that the product may have suffered redundant cutting or slitting. The slitting worker forgot to remove the redundant slitting knives when changing the slitting specifications, and the error may have gone unnoticed during folding, allowing defective products to flow through normal production line. Corrective action: in its scar response, the vendor stated a new requirement was added to the operation procedure that, when changing the slitting specifications, the slitting process cannot start until the assigned person has checked and confirmed the slitting width and position of the slitting knives to prevent errors. Workers have been trained on the new requirement. Investigation summary an internal complaint (b)(4) was received indicating a convenience kit (part 89-7577, lot 50404636) gauze that was separating, creating a risk to the patient. A photo of the defective component was provided to deroyal and shows the separation occurring lengthwise in the middle of the gauze. A sample was returned. However, by the time a sample was available, the investigation was completed with the photo initially provided. The work order for the finished good kit was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The bill of materials for the finished good was reviewed and raw material 5-19928 was identified as the affected component. This gauze is supplied to deroyal by (b)(4). This material comes to deroyal in bulk with stacks of (b)(4) bundled together. These stacks are not unbundled at any time during kit assembly. The defect seen in the customer's photo would not have been observed by deroyal's personnel during assembly. The 2017-2019 scar and supplier notification letter logs were reviewed for similar issues. While past complaints were observed for the reported raw material, no issues similar to the one reported were observed. However, due to the nature of the reported incident, a scar was issued to (b)(4). The investigation is complete at this time. If new and critical information becomes available, this report will be updated.

 
Event Description

The 4-x4 gauze contained in the convenience kit were separating, creating the opportunity to separate inside the body cavity with a potential count error or retained gauze in the body cavity.

 
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Brand NameSURE PACK
Type of DeviceGENERAL 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 Key9155907
MDR Text Key219214424
Report Number3005011024-2019-00014
Device Sequence Number1
Product Code LRO
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK842648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 10/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number89-7577
Device LOT Number50404636
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2019
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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