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

Model Number 89-7447

Device Problems Crack (1135); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint was received indicating that a 10 cc syringe contained within diagnostic angiography pack (finished good (b)(4), lot 44720632) cracked when drawing blood.The defective sample was not available for return.The work order for the reported lot was reviewed for discrepancies that may have contributed to the event.No discrepancies were identified.Lot mapping identified the affected component to be raw material (b)(4) -- a 10 cc syringe supplied to deroyal by (b)(4).A supplier corrective action request (scar) has been issued to (b)(4).As of the date of this report, a response has not been received.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints, and similar complaints were identified.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A 10 cc syringe cracked while the staff was drawing blood into the syringe.The syringe was a component in an diagnostic angiography kit.

Manufacturer Narrative

Root cause: the convenience kit component is supplied to deroyal by becton-dickinson.Therefore, a supplier corrective action request (scar) was issued to bd.In its response, bd stated no root cause can be provided without a sample to investigate.The manufacturer reviewed the dhr and, in its results, found that 15 bulk packaging inspections were performed on 750 parts and zero defects were found; 8 print/assembly inspections were performed on 400 parts and zero defects were found.Corrective action: in its scar response, bd stated no corrective actions can be provided without a sample to investigate.An internal complaint was received indicating that a 10cc syringe contained within diagnostic angiography pack (finished good 89-7447, lot 44720632) cracked when drawing blood.The defective sample was not available for return.The work order for the reported lot was reviewed for discrepancies that may have contributed to the event.No discrepancies were identified.Lot mapping identified the affected component to be raw material 5-20057 -- a 10cc syringe supplied to deroyal by becton-dickinson.A supplier corrective action request (scar) has been issued to becton-dickinson and a response has been received.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints, and similar complaints were identified.Preventive action: a preventive action has not been taken.The investigation is complete.If new and critical information is received, this report will be updated.

Event Description

A 10cc syringe cracked while the staff was drawing blood into the syringe.The syringe was a component in an diagnostic angiography kit.

• Brand Name: DIAGNOSTIC ANGIOGRAPHY PACK
• Type of Device: ANGIOGRAPHY/ANGIOPLASTY KIT
• 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: 6725921
• MDR Text Key: 80579913
• Report Number: 3005011024-2017-00010
• Device Sequence Number: 1
• Product Code: OEQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: ENFORCEMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-7447
• Device Lot Number: 44720632
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2017
• 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