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

Model Number	60729385
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned syringe, lot number 8405573, and identified the presence of a hair-like particle in the fluid path.The particle was detected in the barrel of the syringe and measured approximately 1 cm in length.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.A 12 month review of complaint history determined that there have been no other reported issues of this nature for this lot number.
Event or Problem Description
The site reported the following: after opening the arterion disposable kit and upon filling of the syringe, they saw a hair or hair-like strand of unknown etiology within the fluid.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: 6945570
• Report Number: 2520313-2017-00065
• Device Sequence Number: 1111522
• Product Code: DXT
• UDI-Device Identifier: 00616258005546
• UDI-Public: (01)00616258005546(11)170717
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2017

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: Health Professional
• Device Expiration Date: 07/17/2019
• Device Model Number: 60729385
• Device Catalogue Number: ART 700 SYR
• Device Lot Number: 8405573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2017
• Initial Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1