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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STELLANT CT SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT
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STELLANT CT SYRINGE KIT; ANGIOGRAPHIC SYRINGE KIT Back to Search Results
Model Number 86698242
Medical Device Problem Code Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/09/2021
Type of Reportable Event Malfunction
Event or Problem Description
The customer reported the following: after opening the stellant 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.
 
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.(b)(4).
 
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Brand Name
STELLANT CT SYRINGE KIT
Common Device Name
ANGIOGRAPHIC SYRINGE KIT
MDR Report Key12751908
Report Number2520313-2021-00043
Device Sequence Number4703448
Product Code DXT
UDI-Device Identifier00616258022185
UDI-Public(01)00616258022185
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K082905
Number of Events Summarized1
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 Date12/27/2024
Device Model Number86698242
Device Catalogue NumberSSS-CTP-SPK
Device Lot Number8588477
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/29/2021
Initial Report FDA Received Date11/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured12/27/2020
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 Number1
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