MAUDE Adverse Event Report: BAYER MEDICAL CARE, INC. MEDRAD MRXPERION STERILE DISPOSABLE MRI KIT; ANGIOGRAPHIC SYRINGE KIT, PRODUCT CODE: DXT

Model Number	86594226
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined a photo of the low pressure connector tubing (lpct).Visual examination confirmed the presence of a particle within the tube set.The particle was identified as degraded resin from the tubing extrusion process and was partially connected to the inside wall of the tubing.Our investigation determined that the particle noted in the lpct was introduced during the manufacturing process and was not detected upon receipt of the product from the supplier.A 12 month review of complaint history determined the complaint rate to be 1.30 complaints per million (cpm).
Event or Problem Description
The customer reported the following: after opening an xp 65/115vs disposable syringe kit a foreign material was visualized in the tubing.The customer elected not to use the syringe kit.No injury or adverse event was reported.

• Brand Name: MEDRAD MRXPERION STERILE DISPOSABLE MRI KIT
• Common Device Name: ANGIOGRAPHIC SYRINGE KIT, PRODUCT CODE: DXT
• Manufacturer (Section D): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PW 15051
• Manufacturer (Section G): BAYER MEDICAL CARE, INC.; one bayer drive; indianola PW 15051
• Manufacturer Contact: lois miller ; one bayer drive; indianola, PW 15051 ; 7249407497
• MDR Report Key: 13720530
• Report Number: 2520313-2022-00010
• Device Sequence Number: 5883128
• Product Code: DXT
• UDI-Device Identifier: 00616258021690
• UDI-Public: (01)00616258021690(11)211210(17)241210(10)8418270
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K182276
• 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): 03/10/2022

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: 12/10/2024
• Device Model Number: 86594226
• Device Catalogue Number: XP 65/115VS
• Device Lot Number: 8418270
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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