MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN030893
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "the catheter was inserted in the patient.During the backflow on the mediane line, the nurse observed a white backflow whereas the propofol (propofol is white) was infused via the distale line." it was also reported "patient sedated by propofol in the distal line.Aspiration with the syringe on the median line of white liquid what led us to think of reminiscent of propofol.(no parenteral nutrition in progress, propofol was the only similar therapy).5cc aspirated, without blood reflux, no particular pressure at reflux." no patient harm was reported.The patient remained in the hospital at the time of this report.
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported "the catheter was inserted in the patient.During the backflow on the mediane line, the nurse observed a white backflow whereas the propofol (propofol is white) was infused via the distale line.".It was also reported "patient sedated by propofol in the distal line.Aspiration with the syringe on the median line of white liquid what led us to think of reminiscent of propofol.(no parenteral nutrition in progress, propofol was the only similar therapy).5cc aspirated, without blood reflux, no particular pressure at reflux." no patient harm was reported.The patient remained in the hopsital at the time of this report.

• Brand Name: CVC SET: 4-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11895009
• Report Number: 3006425876-2021-00464
• Device Sequence Number: 3633793
• Product Code: DQY
• UDI-Device Identifier: 10801902029291
• UDI-Public: 10801902029291
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 09/30/2022
• Device Model Number: IPN030893
• Device Catalogue Number: CV-15854
• Device Lot Number: 71F17M0609
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 05/27/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PROPOFOL; PROPOFOL; PROPOFOL