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

Model Number 89-10576

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2020

Event Type  malfunction  

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 Description

The drape included in the convenience kit does not work properly.It continues to allow fluid to leak out, compromising sterility.

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 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
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• 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: 11141190
• MDR Text Key: 242172178
• Report Number: 3005011024-2020-00007
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 00749756364300
• UDI-Public: 00749756364300
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-10576
• Device Lot Number: 52903818
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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