MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN038523
Medical Device Problem Codes	Backflow (1064); Partial Blockage (1065)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "blood backed up into the proximal lumen while continuous medication was administered - proximal (white)".Additional information received reports that norepinephrine was infusing through the white lumen.The rn visualized blood backed up into the lumen while the patient was being repositioned, less than two minutes on their side.The iv pump did not alarm.The rn attempted to flush this lumen and the line had a partial occlusion.It would not draw back blood.The patient did not experience any signs or symptoms related to the event and no patient harm, injury, or health consequence occurred.The vasopressor was moved to another access and cathflo administered for the partial occlusion.The patient's current condition was reported as "expired".Additional information was requested but was not available at the time of this report.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "blood backed up into the proximal lumen while continuous medication was administered - proximal (white)".Additional information received reports that norepinephrine was infusing through the white lumen.The rn visualized blood backed up into the lumen while the patient was being repositioned, less than two minutes on their side.The iv pump did not alarm.The rn attempted to flush this lumen and the line had a partial occlusion.It would not draw back blood.The patient did not experience any signs or symptoms related to the event and no patient harm, injury, or health consequence occurred.The vasopressor was moved to another access and cathflo administered for the partial occlusion.The patient's current condition was reported as "expired".Additional information was requested but was not available at the time of this report.
Additional Manufacturer Narrative
(b)(4) the customer report of blood backflow into catheter was confirmed through complaint investigation of the returned sample.The customer returned one 3-l cvc catheter for evaluation.Initial visual inspection of the catheter revealed no obvious defects or anomalies.Signs of use in the form of biological material was observed on the catheter body.The proximal lumen exit hole appeared typical.The proximal extension line was returned crimped due to the extension line clamp.The proximal extension line length measured 133mm, which was within the specifications of 123-143mm per product drawing.The proximal lumen exit hole was located 49mm from the distal tip, which was within the specifications of 46-54mm per product drawing.These measurements were done via calibrated ruler.Functional inspection was performed per the product ifu which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter lumens were flushed using a lab inventory 10cc syringe.Both the distal and medial lines flushed normally.The proximal line was unable to flush.A long pin gauge was inserted into the proximal line and was able to confirm a blockage within the line.The catheter body was cut to further examine the proximal lumen.Microscopic visual examination reve aled that there was dried biological material within the proximal lumen that was occluding the line.The complaint was confirmed, as the biological material was the evidence of inadequate flow or backflow during use.The biological material was removed from the pr oximal lumen and both pieces of the lumen were flushed using a lab inventory 10cc syringe.The proximal line was then able to flush as intended.The instructions for use (ifu) provided with this kit warns the user, "check for catheter patency: attach 10 ml syringe filled with sterile normal saline.Aspirate catheter for adequate blood return.Vigorously flush catheter.Flush lumen(s) to completely clear blood from catheter." a device history record review could not be performed as no lot number was provided and a potential lot could not be determined from a sales history review.Based on these circumstances, unintentional use error likely caused or contributed to this event.No further action required at this time.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17303286
• Report Number: 9680794-2023-00502
• Device Sequence Number: 6384279
• Product Code: FOZ
• UDI-Device Identifier: 10801902141047
• UDI-Public: 10801902141047
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2023

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 Model Number: IPN038523
• Device Catalogue Number: ASK-45703-PCCH2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 07/11/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOREPINEPHRINE 4.7ML/HR; NOREPINEPHRINE 4.7ML/HR
• Patient Sex: Unknown