MAUDE Adverse Event Report: RAYNHAM ICP SENSOR CATHETER KIT; ICP MICROSENSORS

Catalog Number	826633
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A facility reported a microsensor (id 826633) failed to drain.A physician made two attempts to pulsate with no result; therefore, he decided to test the dve catheter which worked perfectly.Two more attempts was made by the physician using the syringe to aspirate through the pic catheter and since there was no success, it was discarded and used only the dve.A test was performed on the pic catheter, trying to aspirate serum, but did not work.No patient injury reported.
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Updated fields: d9, g3, g6, h2, h3, h4, h6, h11.The microsensor (id (b)(6)) was not returned for evaluation but a video of the event was provided leading to the lodging of this complaint.In the video, the blue cap is tightened, and the user is able to draw liquid up through a syringe through the catheter.The user then loosens the blue cap, which breaks the seal of the system, and they are no longer able to draw liquid up through the catheter with the syringe.The incomplete seal with the loosened blue cap is likely why they were unable to continue drawing up liquid through the catheter with the syringe.Additionally, without having the device back to properly test the product, no additional feedback or conclusion can be made since the only true way to test the product would be to have it back to use in the lab.Device history record (dhr) - there is no indication that the production process may have contributed to this complaint.All test results passed procedural specifications.Root cause analysis - the root cause is undetermined and was unable to be confirmed in the complaint evaluation.Product was not received for analysis and the investigation could not confirm the complaint, the video provided showed the user loosening the blue cap, which is likely what caused the inability to aspirate the liquid.
Event or Problem Description
N/a.

• Brand Name: ICP SENSOR CATHETER KIT
• Common Device Name: ICP MICROSENSORS
• Manufacturer (Section D): RAYNHAM; 325 paramount drive; 325 paramount drive; raynham MA
• Manufacturer (Section G): RAYNHAM; 325 paramount drive; raynham MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ 08540 ; 6099362319
• MDR Report Key: 17730749
• Report Number: 3014334038-2023-00155
• Device Sequence Number: 17752484
• Product Code: GWM
• UDI-Device Identifier: 20886704042331
• UDI-Public: 20886704042331
• Combination Product (Y/N): N
• PMA/510(K) Number: K991222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2024

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: 01/31/2024
• Device Catalogue Number: 826633
• Device Lot Number: J22G03
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 06/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown