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

Model Number	86617439
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned syringe, lot number 8417432.Visual examination identified the presence of a plastic particle on the plunger within the syringe barrel that measured approximately 1mm x 3mm.Our investigation determined that the particle noted in the syringe barrel was most likely introduced during the manufacturing process.A 12 month review of complaint history determined the complaint rate to be 0.91 complaints per million (cpm).
Event or Problem Description
The site reported the following: after opening the arterion disposable kit and upon inspection, they saw a small piece of plastic 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
• Manufacturer (Section G): BAYER MEDICAL CARE INC.; 1 bayer drive; indianola PA 15051
• Manufacturer Contact: diane eckert ; 1 bayer drive; indianola, PA 15051 ; 7249408677
• MDR Report Key: 12908372
• Report Number: 2520313-2021-00047
• Device Sequence Number: 17103836
• Product Code: DXT
• UDI-Device Identifier: 00616258021621
• UDI-Public: (01)00616258021621
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K113133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/01/2021

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: 05/13/2023
• Device Model Number: 86617439
• Device Catalogue Number: ART 700 SYR
• Device Lot Number: 8417432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown