MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC SPECTRIS SOLARIS SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT

Model Number SSQK 65/115VS

Device Problems Break (1069); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 02/19/2015

Event Type  malfunction  

Event Description

The site reported the following: upon spiking a bottle of saline with the spike of the syringe kit, a piece of the rubber stopper broke off and became dislodged, floating in the vial.

Manufacturer Narrative

Bayer medical care quality product analysis reviewed the info that was provided by the site and is awaiting the return of the product in order to conduct an investigation.In the event add'l info is obtained, a follow up report will be submitted.

• Brand Name: SPECTRIS SOLARIS SYRINGE KIT
• Type of Device: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC; indianola PA
• Manufacturer Contact: dianne eckert ; 1 bayer dr; indianola, PA 15051 ; 7249408677
• MDR Report Key: 4613469
• MDR Text Key: 5654758
• Report Number: 2520313-2015-00016
• Device Sequence Number: 1
• Product Code: DXT
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SSQK 65/115VS
• Device Catalogue Number: SSQK 65/115VS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1