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

Model Number	89-7059
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (b)(4) was received indicating that a convenience kit (finished good 80-7049, lot 47987324) contained a syringe that was leaking.The end user reported that the syringe plunger was loose and allowing air to enter the line when pushing fluids.A sample was returned to deroyal for evaluation.The complaint investigator performed a test on the returned sample to see if air bubbles leaked into the syringe.The test confirmed the customer's complaint.Air bubbles were seen forming around the seal of the plunger.The finished good work order was reviewed for possible discrepancies that may have contributed to the reported issue.No discrepancies were identified.The bill of material for the finished kit was reviewed to identify the affected component, which was determined to be raw material (b)(4), a 20cc luer lock syringe.This raw material syringe is supplied to deroyal by (b)(4).A supplier corrective action request (scar) was issued to (b)(4).The returned sample also was forwarded to (b)(4) for evaluation on october 3, 2018.As of the date of this report, a response has not been received.The 2016-2018 scar and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified.Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.
Event or Problem Description
The 20ml luer lock syringe contained in the convenience kit is leaking and the plunger is loose.Air is getting into the line when pushing fluids.
Additional Manufacturer Narrative
Root cause: the syringe component is supplied to deroyal by welmed.Deroyal issued a supplier corrective action response (scar) to welmed and sent photos and samples of defective product.In its response to the scar, welmed stated that these samples and pictures were received but not forwarded to the manufacturing facility for testing due to time.Welmed stated that, based on past experience, the root cause may be (1) cracks or defects in the first sealing of the rubber plug or (2) unexpected clinical use of the syringes on injection pumps.Corrective action: in its scar response, welmed stated that it contacted its plug supplier to investigate the reported issue and formulate preventive measures to prevent similar issues from happening.The plug also will be checked for defects and cracks during purchase inspection.Investigation summary an internal complaint (call 45216) was received indicating that a convenience kit (finished good 89-7049, lot 47987324) contained a syringe that was leaking.The end user reported that the syringe plunger was loose and allowing air to enter the line when pushing fluids.A sample was returned to deroyal for evaluation.The complaint investigator performed a test on the returned sample to see if air bubbles leaked into the syringe.The test confirmed the customer's complaint.Air bubbles were seen forming around the seal of the plunger.The finished good work order was reviewed for possible discrepancies that may have contributed to the reported issue.No discrepancies were identified.The bill of material for the finished kit was reviewed to identify the affected component, which was determined to be raw material 5-19834, a 20cc luer lock syringe.This raw material syringe is supplied to deroyal by welmed.A supplier corrective action request (scar) was issued to welmed.The returned sample also was forwarded to welmed for evaluation on october 3, 2018.A response was received and accepted by deroyal personnel on october 23, 2018.The defective samples and photos were sent to welmed for evaluation.These samples were received but not forwarded to the manufacturing facility for testing.In its scar response, welmed stated samples available at the manufacturing facility were tested and no defective or cracked rubber stoppers were identified.Welmed's investigator also checked production batch records and no abnormal conditions in the production process were identified.The 2016-2018 scar and supplier notification letter logs were reviewed for similar complaints.Similar complaints were identified.Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs.Preventive action: welmed has indicated that they have retrained the assembly workers, who are required to check whether there is any defect or indentation around the piston seal ring.The investigation is incomplete at this time.When the defective samples that deroyal forwarded to the supplier are tested, this report will be updated.
Event or Problem Description
The 20ml luer lock syringe contained in the convenience kit is leaking and the plunger is loose.Air is getting into the line when pushing fluids.

• Brand Name: CATH PACK
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 7978634
• Report Number: 3005011024-2018-00005
• Device Sequence Number: 19271234
• Product Code: OEQ
• UDI-Device Identifier: 00749756735674
• UDI-Public: 00749756735674
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,Followup
• Report Date (Section B): 11/12/2018

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: 89-7059
• Device Lot Number: 47987324
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1