MAUDE Adverse Event Report: DEROYAL INDUSTRIES ST. JOHN KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 77-401026

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Drew air into syringe each time the dr.Tried to draw contrast.

• Brand Name: ST. JOHN KIT
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES; 1501 east central ave.; lafollette TN 37766
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8563622333
• MDR Report Key: 4040613
• MDR Text Key: 4901588
• Report Number: 3005011024-2014-00008
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2017
• Device Catalogue Number: 77-401026
• Device Lot Number: 35774516
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/11/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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