MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. ANGIO PACK; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	89-10367
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (part 89-10367, lot 52924707) that contained an angio drape that leaked during use.A sample was not available for evaluation.The work order for the reported finished good lot was reviewed for discrepancies that may have contributed to the event.No discrepancies were identified.The affected kit component was identified as raw material 704411, which is supplied to deroyal by o & m halyard.The raw material inventory on hand was inspected, but no issues were found with the available inventory.Due to the nature of the reported issue, a supplier corrective action request (scar) was issued to o & m halyard.As of the date of this report, a response has not been received.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.Due to employee oversight, this report is being submitted outside the 30-day requirement.
Event or Problem Description
An angio drape contained within a convenience kit leaked uring use.
Additional Manufacturer Narrative
Root cause: no root cause was established due to the lack of sample and no information on duration of procedure.The spec allows a percentage of strikethrough.Only a picture was shared from a table with some reddish fluid.Corrective action: per the scar response, o & m halyard medical stated no root cause was established to take a corrective action.Verification will be measured through the complaint system.The investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: ANGIO PACK
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 11392890
• Report Number: 3005011024-2021-00002
• Device Sequence Number: 17155891
• Product Code: OEQ
• UDI-Device Identifier: 00749756991889
• UDI-Public: 00749756991889
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: ENFORCEMENT
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2021

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: 89-10367
• Device Catalogue Number: 89-10367
• Device Lot Number: 52924707
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 03/01/2021
• Supplement Report FDA Received Date: 04/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1