MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15272-VF
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the catheter is pulling air bubbles near the arterial portion of the catheter where the lumens meet the cuff.Product is still in patient.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Event or Problem Description
It was reported that: the catheter is pulling air bubbles near the arterial portion of the catheter where the lumens meet the cuff.Product is still in patient.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.
Additional Manufacturer Narrative
(b)(4).The customer report of leaking juncture hub was confirmed through complaint investigation of the returned sample.The customer returned one chronic hemodialysis catheter assembly for evaluation.Signs-of-use were observed on the returned assembly.Initial visual inspection of the catheter showed no defects or anomalies.Further visual analysis was performed after functional inspection of the sample.The connector was disassembled, and it was noted that the green compression sleeve was missing from the assembly.The ifu states, "after the tip has been positioned, the proximal end of the catheter is tunnelled retrograde to the exit site.The separate hub connection assembly is then fastened to the proximal end of the catheter using a compression sleeve and threaded compression cap." this indicates the user did not assemble the catheter correctly per the ifu.The returned catheter assembly was flushed using a lab inventory 10ml syringe.A leak was observed at the level of the juncture hub, originating from the compression cap.The returned ca theter was disassembled to further examine the source of the leak.It was observed that the green compression sleeve was not present in the assembly.The catheter was then reassembled using a lab inventory green compression sleeve, and the functional test was repe ated.This time, the leak was no longer present at the level of the juncture hub.This indicates the leak was caused by the missing green compression sleeve.The instructions-for-use (ifu) provided with this kit warns the user, "warning: green compression sleeve must be present when threading compression cap onto hub connection assembly.Failure to do so may result in air embolism, blood loss, or catheter separation." a device history record review was performed based on a potential lot number from sales history, and no relevant findings were identified.Based on the customer report and the sample received, intentional use error likely caused or contributed to this event.The customer was informed that the improper assembly of this device contributed to the observed failure mode.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 27 CM RETR
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: 18318661
• Report Number: 9680794-2023-01002
• Device Sequence Number: 7316531
• Product Code: MSD
• UDI-Device Identifier: 00801902090201
• UDI-Public: 00801902090201
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2023

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
• Device Catalogue Number: CS-15272-VF
• Device Lot Number: 33F23D0864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/08/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown