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

Model Number 89-6506

Device Problems Hole In Material (1293); Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2016

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (call (b)(4) was received regarding two set up packs (finished good 89-6506, lot number 42690687) that contained four gowns with holes in the cuffs.Representative samples were returned for evaluation.The actual defective sample was not available.The work order was reviewed for possible discrepancies that may have contributed to the reported issue.No discrepancies were found.The bill of materials (bom) for the finished good tray was reviewed.It identified that two gowns are contained within the finished good: (b)(4) number (b)(4) (gown surgical extra large) and raw material number (b)(4) (gown surgical large).Lot mapping confirmed that both raw materials are supplied by halyard health.A supplier corrective action report (scar) has been issued to halyard health.A response has not been received at the time of this report.The scar and supplier notification letter (snl) logs for 2014 to present were reviewed for similar complaints.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

Two set up packs have had four gowns with holes in the cuffs.The end user threw away the pack, used a couple of the gowns, and opened up a sterile sleeve to cover the holes.

Manufacturer Narrative

Root cause: the gowns contained within the finished good kit were supplied to deroyal by halyard health.Therefore, a supplier corrective action request (scar) was issued to halyard.In its response, halyard stated the root cause is unknown due to the absence of defective samples for evaluation.A potential root cause of use error was identified.Corrective action: in its scar response, halyard identified the following corrective actions for tear/cut/hole incidents in gowns: verification of work station structure conditions; verification of procedures and work instructions; and training all involved personnel on cutting and sub-assembly procedures.Investigation summary an internal complaint (b)(4) was received regarding two set up packs (finished good 89-6506, lot number 42690687) that contained four gowns with holes in the cuffs.Representative samples were returned for evaluation.The actual defective sample was not available.During evaluation of these representative samples, no holes, cuts, or tears in the cuffs were identified.The work order was reviewed for possible discrepancies that may have contributed to the reported issue.No discrepancies were found.The bill of materials (bom) for the finished good tray was reviewed.It identified that two gowns are contained within the finished good: raw material (b)(4) (gown surgical extra large) and raw material number (b)(4) (gown surgical large).Lot mapping confirmed that both raw materials are supplied by halyard health.Follow-up was conducted to inquire in which of the two gowns the reported issue occurred.Follow-up communication indicated the reported issue occurred in both gowns.A scar was issued to halyard health and a response was received november 29, 2016.Preventive action: in its scar response, halyard identified the following preventive actions for tear/cut/hole incidents in gowns: maintenance procedure evaluation and training all involved personnel on structure maintenance procedure.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.

Event Description

Two set up packs have had four gowns with holes in the cuffs.The end user threw away the pack, used a couple of the gowns, and opened up a sterile sleeve to cover the holes.

• Brand Name: SET UP 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: 6043744
• MDR Text Key: 57981136
• Report Number: 3005011024-2016-00029
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-6506
• Device Lot Number: 42690687
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2016
• 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