MAUDE Adverse Event Report: MEDRAD STELLANT FLEX SYRINGE KITS; ANGIOGRAPHIC SYRINGE

Model Number	87078817
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Bayer product analysis received and examined the returned product.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 0.31 complaints per million (cpm).
Event or Problem Description
The customer reported the following: after opening the stellant flex ct disposable kit and upon inspection, they saw a foreign body within the low pressure connector tubing (lpct).The customer elected not to use the tubing.No injury or adverse event was reported.

• Brand Name: MEDRAD STELLANT FLEX SYRINGE KITS
• Common Device Name: ANGIOGRAPHIC SYRINGE
• MDR Report Key: 12752547
• Report Number: 2520313-2021-00044
• Device Sequence Number: 20009469
• Product Code: DXT
• UDI-Device Identifier: 00616258022888
• UDI-Public: (01)00616258022888
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K192370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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: 08/03/2025
• Device Model Number: 87078817
• Device Catalogue Number: FLEXD-150-SCS
• Device Lot Number: 8601877
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2021
• 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