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

Model Number	IPN030893
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Customer reported "the staff faced an inadequate flow rate with this device.During use on the patient.This patient has an unstable blood pressure." it was also reported "there were significant variations in blood pressure.Appears to correlate with midline therapy boluses.Patient under nicotinamide adenine dinucleotide on proximal line.Installation of peripheral line for administration of noradrenaline in order to eliminate the doubt: in blood pressure variations continued.".
Event or Problem Description
Customer reported "the staff faced an inadequate flow rate with this device.During use on the patient.This patient has an unstable blood pressure." it was also reported "there were significant variations in blood pressure.Appears to correlate with midline therapy boluses.Patient under nicotinamide adenine dinucleotide on proximal line.Installation of peripheral line for administration of noradrenaline in order to eliminate the doubt: in blood pressure variations continued.".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11894876
• Report Number: 3006425876-2021-00463
• Device Sequence Number: 3633792
• 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: No Information
• Device Expiration Date: 02/28/2025
• Device Model Number: IPN030893
• Device Catalogue Number: CV-15854
• Device Lot Number: 71F20F0635
• Was Device Available for Evaluation?: Yes
• 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: NICOTINAMIDE ADENINE DINUCLEOTIDE; NICOTINAMIDE ADENINE DINUCLEOTIDE; NICOTINAMIDE ADENINE DINUCLEOTIDE