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

Model Number	50-13119
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint ((b)(4)) was received for a cardiac catheterization tray (finished good 50-13119, lot 46982046), which indicated there was lint and loose threads on a towel contained within the tray.A sample was returned to deroyal for review.The returned sample did contain loose threads.The investigator reviewed the work order for possible discrepancies that may have contributed to the reported issue.No discrepancies were identified.The bill of materials for the finished good was reviewed, and the affected (b)(4) material was identified as part number 5-5338, a green operating room towel.Lot mapping shows that this towel is supplied to deroyal by (b)(4).A supplier notification letter was sent to (b)(4) to notify them of the reported event.The returned sample also was forwarded to (b)(4) and was received may 16, 2018.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
Towels contained in a cardiac cath tray are linting.Random loose strands of thread are falling off of the towels.The end user is concerned the lint or thread could end up in a heart catheter.
Event or Problem Description
Towels contained in a cardiac cath tray are linting.Random loose strands of thread are falling off of the towels.The end user is concerned the lint or thread could end up in a heart catheter.
Additional Manufacturer Narrative
Root cause: the towel manufacturer, gd medical, stated in its supplier corrective action request that it determined the root cause to be an inadequate inspection process and poor attention to detail during manufacturing.Corrective action: in its scar response, gd medical indicated applicable personnel were re-trained on the inspection process to ensure product is released within specification and without loose threads.Investigation summary an internal complaint (call 44134) was received for a cardiac catheterization tray (finished good 50-13119, lot 46982046), which indicated there was lint and loose threads on a towel contained within the tray.A sample was returned to deroyal for review.The returned sample did contain loose threads.The investigator reviewed the work order for possible discrepancies that may have contributed to the reported issue.No discrepancies were identified.The bill of materials for the finished good was reviewed, and the affected raw material was identified as part number 5-5338, a green operating room towel.Lot mapping shows that this towel is supplied to deroyal by gd medical.A supplier notification letter was sent to gd medical to notify them of the reported event.The returned sample also was forwarded to gd medical and was received may 16, 2018.A response from gd medical was received.Preventive action: in its scar response, gd medical stated it implemented the following preventive actions: tightened inspection, line clearance process, and employee training.The investigation is complete at this time.If new and critical information is received, this report will be updated.

• Brand Name: CARDIAC CATHETER TRAY
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 7561356
• Report Number: 3005011024-2018-00002
• Device Sequence Number: 1754460
• Product Code: OEQ
• UDI-Device Identifier: 00749756248686
• UDI-Public: 0749756248686
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2018

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: 50-13119
• Device Lot Number: 46982046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 06/01/2018
• Supplement Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1