MAUDE Adverse Event Report: BAYER MEDICAL CARE INC MEDRAD STELLANT DISPOSABLE INJECTOR SYRINGE; SYRINGE, PISTON

Lot Number 8516153

Device Problems Sticking (1597); Physical Property Issue (3008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  malfunction  

Event Description

After filling the syringe with iodinated contrast solution the removable white spike adaptor (included in the syringe set) becomes stuck to the syringe tip.The white spike adaptor normally screws on and off after the syringe is filled with contrast.On a few occasions the white spike appears to be stuck and does not easily unscrew.With force, the white spike adaptor is able to be unscrewed, but this damages the tip of the syringe and is no longer a usable device.

• Brand Name: MEDRAD STELLANT DISPOSABLE INJECTOR SYRINGE
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BAYER MEDICAL CARE INC; 150 victory road; saxonburg PA 16056
• MDR Report Key: 6212317
• MDR Text Key: 63533826
• Report Number: 6212317
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Expiration Date: 01/01/2020
• Device Lot Number: 8516153
• Other Device ID Number: MANUFACTIRE DATE 01/2016
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/25/2016
• Device Age: 1 DY
• Date Report to Manufacturer: 11/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1