MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. PERCUTANEOUS TRAY; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	89-5525
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Root cause: in its scar response, (b)(4) stated that every bundle of sponges goes through an automatic counting machine for piece count verification.It is possible the reported incident is the result of a manufacturing error in which an employee accidentally retained the wrong piece count bundle instead of rejecting it.Corrective action: the vendor reported in its scar that training on the piece count machine operation procedure and additional inspections will be performed.Investigation summary: an internal complaint ((b)(4)) was received indicating that a convenience kit (part 89-5525, lot 47941027) contained a pack of lap sponges with seven pieces instead of five.The end user reported this incident to the fda.The defective sample was not returned for evaluation.The deroyal complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials was reviewed and it was determined the affected raw material component was part 5-1819, a lap sponge pack supplied to deroyal by (b)(4).This pack comes to deroyal in bulk in bundled stacks of five.Deroyal employees do not unbundle these stacks at any point during the kit assembly process.Therefore, the reported non-conformance was determined to be a vendor issue.The supplier corrective action request (scar) and supplier notification letter logs were reviewed for the years 2016-2018 for similar issues.Previous issues similar to the reported complaint were identified, and a new scar was issued to (b)(4).A response has been received and accepted by deroyal's complaint investigator.Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.
Event or Problem Description
The convenience kit contained seven sponges when there only should have been five.

• Brand Name: PERCUTANEOUS TRAY
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 7990250
• Report Number: 3005011024-2018-00006
• Device Sequence Number: 13873501
• Product Code: OEQ
• UDI-Device Identifier: 00749756640473
• UDI-Public: 00749756640473
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: ENFORCEMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2018

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: 89-5525
• Device Lot Number: 47941027
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 10/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1