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

Model Number	85232924
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the limited information, we are unable to determine the root cause of the unknown particle at this time; however, the product is scheduled to return to bayer for a full evaluation.Once the evaluation is completed, a follow-up report will be submitted.
Event or Problem Description
The customer reported the following: after opening the arterion disposable syringe kit and upon inspection, they saw a foreign body within the syringe tip.The customer elected not to use the tubing.No injury or adverse event was reported.
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned syringe kit.Visual examination confirmed the presence of a fully embedded dark colored particulate within the fasturn nut.Our investigation determined that the particle was introduced into the syringe during the injection molding process.Product analysis concluded that, due to the particulate being embedded within the syringe material, the potential of injection into a patient does not exist.

• 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: 9245099
• Report Number: 2520313-2019-00049
• Device Sequence Number: 17076435
• Product Code: DXT
• UDI-Device Identifier: 00616258010069
• UDI-Public: (01)00616258010069
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: Health Professional
• Device Expiration Date: 09/05/2020
• Device Model Number: 85232924
• Device Catalogue Number: ART 700 SYR
• Device Lot Number: 8409190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1