MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-45703-PLGH2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the catheter was inserted on (b)(6) 2023 and the microclave needle-less connector was attached.The tip of the microclave broke and the plunger malfunctioned.The device was replaced with another device successfully.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).
Additional Manufacturer Narrative
(b)(4).The report of a damage luer hub was confirmed through complaint investigation of the returned sample.The customer provided one image for analysis.Visual analysis revealed that the proximal end of the valve was damaged.The customer returned one, defective luer-activated valve for analysis.A white, powdery substance was noted on the outside surface.This substance appears consistent with medication and is an indication that the component was used.Visual analysis revealed that the proximal end of the valve was separated.The severed end was not returned for analysis.Microscopic examination confirmed the separation and revealed that the edges were jagged.White stress marks were also observed, which is damage consistent with a stress related break.Functional analysis could not be performed as part of this complaint investigation due to the severity of the damage.R & d unit indicated that a significant force would be required to create this damage as this component is made of sturdy plastic.Based on the appearance of the separation, undue force caused or contributed to this event.The ifu provided with the kit informs the user, "use only securely tightened luer-lock connections with any central venous access device to guard against inadvertent disconnection".The ifu also states, "connect all extension line(s) to appropriate luer-lock connector(s) as required.Unused port(s) may be 'locked' through luer-lock connector(s) using standard institutional policies and procedures".A device history record review was performed, and no relevant findings were identified.Based on the customer report, the sample received, and the comments from r & d, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: the catheter was inserted on 12/29 and the microclave needle-less connector was attached.The tip of the microclave broke and the plunger malfunctioned.The device was replaced with another device successfully.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.

• Brand Name: PI CVC KIT: 3L 7 FR X 8 IN (20 CM) AGB+
• 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: 18594719
• Report Number: 9680794-2024-00097
• Device Sequence Number: 6660133
• Product Code: FOZ
• UDI-Device Identifier: 10801902144536
• UDI-Public: 10801902144536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: ASK-45703-PLGH2
• Device Lot Number: 33F23C0139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 02/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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