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

Model Number 89-7019

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary an internal complaint (b)(4) was received indicating that a 10cc syringe contained within an angiography pack (part number 89-7019) split down the side, allowing facility staff to become exposed to blood.A sample was not available for return.The syringe is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request was issued to (b)(4) on april 20, 2017.A response is due june 1, 2017.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A 10cc syringe contained within the angiography pack splint down the side, allowing the surgeon and tech to be exposed to blood.

Manufacturer Narrative

Root cause: the convenience kit component is supplied to deroyal by bd.Therefore, a supplier corrective action request (scar) was issued to bd.In its response, the supplier stated that the root cause is unknown.No issues were reported during the manufacturing of the reported batch.Without a sample to evaluate, it is not possible to conclude whether the defect occurred during manufacturing or post-manufacture handling.Corrective action: in its scar response, bd stated no corrective actions are necessary at this time.An internal complaint (call 40590) was received indicating that a 10cc syringe contained within an angiography pack (part number (b)(4) split down the side, allowing facility staff to become exposed to blood.Upon further discussion with the customer, it was found that even though the surgeon and tech were exposed to blood during the procedure, no medical attention was needed.A sample was not available for return.The work order was reviewed for possible discrepancies.No discrepancies were identified.Lot mapping identified the affected raw material as (b)(4) (10cc syringe luer slip, lot 6204645).This raw material component is supplied to deroyal by becton-dickinson.A scar was issued to bd on (b)(6) 2017.A response has been received.The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.No similar complaints were identified.Preventive action: in its scar response, bd stated a preventive action is not recommended at this time.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A 10cc syringe contained within the angiography pack split down the side, allowing the surgeon and tech to be exposed to blood.

• Brand Name: 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: 6545985
• MDR Text Key: 74497163
• Report Number: 3005011024-2017-00007
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-7019
• Device Lot Number: 44357626
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2017
• 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