MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15232-VFE
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "a bump was observed on the venous line before connection." the defect was found prior to use.Therefor no patient harm or injury.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "a bump was observed on the venous line before connection." the defect was found prior to use.Therefor no patient harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4) the actual device was not returned; however, the customer provided one photo for analysis.The venous extension line was observed to be ballooned directly proximal to the pinch clamp.It was also noted that the pinch clamp was in the locked position.The locking of the pinch clamp in combination with over-pressurizing can result in the observed failure; however, it is unknown if the pinch clamp was locked at the time of the event.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not clamp tubing repeatedly in the same place.Doing so may weaken the tubing".The ifu also states, "avoid clamping near luer-lock fittings".The ifu also states, "open catheter clamp prior to infusion through lumen".The report of a ballooned extension line was confirmed through analysis of the customer supplied photo.Visual analysis revealed that the venous extrusion was ballooned directly proximal to the pinch clamp.It was also noted that the pinch clamp was in the locked position.The ifu clearly states to "open catheter clamp prior to infusion through lumen"; however, it is unknown if the clamp was in the locked position at the time of the event time of the event.Therefore, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19013100
• Report Number: 9680794-2024-00295
• Device Sequence Number: 7993772
• Product Code: MSD
• UDI-Device Identifier: 10801902127256
• UDI-Public: 10801902127256
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Device Catalogue Number: CS-15232-VFE
• Device Lot Number: 33F23K0176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 04/01/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown