MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number	AK-22142-CDC
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that: the 3-0 silk with curved needle that comes in the arrowgard blue two lumen hemodialysis catheterization kit, size 14fr 20cm.The suture needle broke off and was left in the patient.The patient was transferred to the ir suites for removal of the needle.The patient remained stable throughout.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the 3-0 silk with curved needle that comes in the arrowgard blue two lumen hemodialysis catheterization kit, size 14fr 20cm.The suture needle broke off and was left in the patient.The patient was transferred to the ir suites for removal of the needle.The patient remained stable throughout.
Additional Manufacturer Narrative
(b)(4).The customer returned one suture needle for investigation.Visual examination revealed that the suture needle was broken and separated at the proximal end.Definite signs of use were observed as there was biological material at the point of separation.Microscopic examination revealed that the point of separation was rough/jagged.Functional analysis could not be performed due to the condition of the returned suture needle.R & d engineering was previously contacted about complaints of this nature.They concluded that this failure mode should be further investigated by the supplier of the component.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit instructs the user, "use triangular juncture hub with integral rotating suture wings as primary suture site.The removable suture wing, where provided, may be used as a secondary suture site.Place fingers on the suture wings and apply pressure until the hub splits open.Position suture wing around the catheter body adjacent to the venipuncture site.Secure wings in place to patient, using suturing technique per institutional policies." the report of a broken suture needle during use was confirmed through complaint investigation of the returned sample.Visual examination revealed that the suture needle was broken and separated at the proximal end.Definite signs-of-use were observed as there was biological material at the point of separation.Microscopic examination revealed that the point of separation was rough/jagged.R & d engineering concluded that the supplier likely caused or contributed to the failure mode.A non-conformance as initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: HEMODIALYSIS KIT 2L: 14 FR X 15CM AGB
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18612786
• Report Number: 1036844-2024-00004
• Device Sequence Number: 20710074
• Product Code: MPB
• UDI-Device Identifier: 50801902123157
• UDI-Public: 50801902123157
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K993933
• 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): 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2024
• Device Catalogue Number: AK-22142-CDC
• Device Lot Number: 33F23H0055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown