MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. 150 FASTURN SYRINGE KIT W/QFT; ANGIOGRAPHIC SYRINGE KIT

Model Number	60729636
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer radiology product analysis received and examined the returned syringe, lot number 8403956, and identified the presence of a thin strand of hair in the fluid path.The particle was detected in the barrel of the syringe and measured approximately 114 mm in length and 0.02 mm in width.Comparison of the particle with the inside diameter of the range of catheters used for radiology injection concluded that the potential of injection into the patient exists.Our investigation determined that the particulate noted in the syringe was introduced during the material handling in the manufacturing process and was not detected upon receipt of the syringe from the supplier.The syringe kit instructions for use instructs the user to "visually inspect contents and package before each use".This visual inspection is to ensure particulates are noticed and mitigated, which is what occurred in this reported instance.
Event or Problem Description
The site reported the following: upon opening the provis syringe kit and inspecting the contents, the technologist noticed a thin, hair-like foreign body within the syringe barrel.The customer elected not to use the syringe.No injury or adverse event was reported.

• Brand Name: 150 FASTURN SYRINGE KIT W/QFT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; 1 bayer drive; indianola PA 15051
• MDR Report Key: 6347007
• Report Number: 2520313-2017-00012
• Device Sequence Number: 19012745
• Product Code: DXT
• UDI-Device Identifier: 10616258005604
• UDI-Public: (01)10616258005604(11)161012(17)191012(10)8403956
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K822536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/21/2017

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
• Operator of Device: Radiologic Technologist
• Device Expiration Date: 10/12/2019
• Device Model Number: 60729636
• Device Catalogue Number: 150-FT-Q
• Device Lot Number: 8403956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2017
• Initial Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1