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

Model Number	IPN915623
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the cardio thoracic surgeon trimmed the end of the catheter while performing surgery on the heart.The catheter was cut after placement, not prior to placement.There was "an unusual white rubber piece noted in one of the lumens, which was adherent within the catheter".The customer reported the surgeon trims the tip of the catheter because "the end is near the site of surgical repair in the heart and they don't want healing impaired.When the catheter is too long it's near the surgical site and in the field of surgery making it difficult to work around".The patient's current condition was unknown.It was reported "no immediate harms reported".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the cardio thoracic surgeon trimmed the end of the catheter while performing surgery on the heart.The catheter was cut after placement, not prior to placement.There was "an unusual white rubber piece noted in one of the lumens, which was adherent within the catheter".The customer reported the surgeon trims the tip of the catheter because "the end is near the site of surgical repair in the heart and they don't want healing impaired.When the catheter is too long it's near the surgical site and in the field of surgery making it difficult to work around".The patient's current condition was unknown.It was reported "no immediate harms reported".
Additional Manufacturer Narrative
Qn#(b)(4).The customer report of foreign material inside the catheter was not able to be confirmed by visual inspection of the customer supplied photo.The customer provided one photo showing a catheter for analysis; a white substance was observed inside the catheter; however, the substance was identified during use, and it cannot be confirmed if this was a foreign material that was present prior to use without the sample returned for analysis.The ifu provided with the kit informs the user, "aspirate, then flush catheter lumen using 10 ml syringe or larger filled with sterile normal saline".A device history record review was performed based on sales history, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17321537
• Report Number: 9680794-2023-00511
• Device Sequence Number: 15083969
• Product Code: FOZ
• UDI-Device Identifier: 10801902162080
• UDI-Public: 10801902162080
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (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): 06/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: IPN915623
• Device Catalogue Number: CDC-42703-XPCN1A
• Device Lot Number: UNKNOWN
• 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: 06/21/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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