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

Model Number	89-10576
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary a medwatch (b)(4) was received indicating a drape contained within a convenience kit (part 89-10567, lot 52903818) allowed fluid to leak.This was entered as an internal complaint (b)(4).A sample was not returned for evaluation.The work order 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 to identify the affected drape component.There are three drapes contained within the convenience kit.Therefore, the initial reporter was contacted to identify to which drape the report referred.An initial request was sent december 10 and a follow up request on december 28).As of the date of this report, a response has not been received.The investigation is incomplete at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
The drape included in the convenience kit does not work properly.It continues to allow fluid to leak out, compromising sterility.
Additional Manufacturer Narrative
Root cause: the irrigation drape is supplied to deroyal by advance medical design, inc.Therefore, a supplier corrective action request (scar) was issued to advance medical design.In its response, the supplier stated the root cause is unknown.They were unable to identify any damages or leaks in the device.Corrective action: per its scar response, advanced medical design stated its incoming inspection will be increased to sample a larger incoming sample size.If there is an issue with the drapes, a larger sample size should identify the issue at incoming.Investigation summary a medwatch (report (b)(4) was received indicating a drape contained within a convenience kit (part 89-10567, lot 52903818) allowed fluid to leak.This was entered as an internal complaint ((b)(4)).A sample was not returned for evaluation.Clarification was requested as to where the drape was leaking.However, the initial reporter stated no additional information was available.The work order 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 to identify the affected drape component.There are three drapes contained within the convenience kit.Therefore, the initial reporter was contacted to identify to which drape the report referred.An initial request was sent december 10 and a follow up request on december 28.On december 29, confirmation was received that the affected drape was raw material (b)(4), which is an irrigation drape supplied by advance medical design.A scar was issued to advance medical design.A response was received january 14, 2021 and accepted by deroyal personnel.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
The drape included in the convenience kit does not work properly.It continues to allow fluid to leak out, compromising sterility.

• Brand Name: OB OR C-SECTION PACK
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 11141190
• Report Number: 3005011024-2020-00007
• Device Sequence Number: 13622251
• Product Code: KDD
• UDI-Device Identifier: 00749756364300
• UDI-Public: 00749756364300
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-10576
• Device Lot Number: 52903818
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/08/2021
• Supplement Report FDA Received Date: 03/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1