MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	CDC-42703-XPN1A
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi# (b)(4).
Event or Problem Description
The report states: "79 yo male had computed tomography angiography chest (r/o pulmonary embolism).Upon administration of flush, blue lumen of central venous catheter expanded and split 2/3 of the external length of said lumen.The line was then clamped and another lumen used for completion of the exam.The patient did not c/o any issues.No evidence of infiltration at site nor evidence of catheter damage distally on imaging /no extravasation of site either.Central line was identified as power injectable.Patency of the line was obtained by rad tech without incidence.Hand saline flush was completed without incidence.Power injector line was connected to lumen with 5ml/sec marked on the hub." 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).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
The report states: "79 yo male had computed tomography angiography chest (r/o pulmonary embolism).Upon administration of flush, blue lumen of central venous catheter expanded and split 2/3 of the external length of said lumen.The line was then clamped and another lumen used for completion of the exam.The patient did not c/o any issues.No evidence of infiltration at site nor evidence of catheter damage distally on imaging /no extravasation of site either.Central line was identified as power injectable.Patency of the line was obtained by rad tech without incidence.Hand saline flush was completed without incidence.Power injector line was connected to lumen with 5ml/sec marked on the hub." 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: ARROW PI CVC KIT: 3-L 7 FR X 16 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19759839
• Report Number: 9680794-2024-00695
• Device Sequence Number: 6513653
• Product Code: FOZ
• UDI-Device Identifier: 10801902162066
• UDI-Public: (01)10801902162066(11)240220(17)250731(10)33F24A0205(21)
• 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): 06/24/2024

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: 07/31/2025
• Device Catalogue Number: CDC-42703-XPN1A
• Device Lot Number: 33F24A0205
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2024
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 90 KG