MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4-L 8.5FR X 16CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN904985
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: "cvc quad line noted to have leak on the blue portion of infusion port where the line is secured by stitches and diverges into the 4 infusion ports.Leak was discovered after the patient's proximal port on the central line was beeping occluded.Cath flo was administered and when pulling back on line with a syringe to check for blood return the syringe filled with air.Line placed on (b)(6) 2022 and was removed on (b)(6) when leak discovered.".No patient harm reported.The patient's condition is reported as fine.
Event or Problem Description
The complaint is reported as: "cvc quad line noted to have leak on the blue portion of infusion port where the line is secured by stitches and diverges into the 4 infusion ports.Leak was discovered after the patient's proximal port on the central line was beeping occluded.Cath flo was administered and when pulling back on line with a syringe to check for blood return the syringe filled with air.Line placed on (b)(6) 2022 and was removed on (b)(6) when leak discovered.".No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 4-l cvc for analysis.Signs of use in the form of biological material were observed inside the catheter and extension lines.Visual inspection revealed that a hole had formed in the catheter juncture hub.The material around the hole was blown outwards.The appearance of the defect is consistent with damage due to over-pressurization of the catheter during use.Microscopic examination confirmed the damage.The total catheter length from the juncture hub to the distal tip measured 169 mm which is within the specification limits of 157mm-177mm per the catheter graphic.The catheter body outer diameter measured 2.91mm which is within the specification limits of 2.87mm-2.97mm per the catheter extrusion graphic.With the distal end manually occluded with a clamp, the extension lines were flushed with a 5cc lab inventory syringe.When the proximal lumen was flushed, water was observed leaking out of the defect on the juncture hub.No leaks or defects were observed when flushing the remaining extension lines.The clamp was removed, and the proximal lumen was flushed again.Water was observed leaking out of the hole in the juncture hub, but not the proximal skive hole.This indicated the presence of a blockage in the proximal extension line.A lab inventory guide wire with diameter 0.64 mm was used to attempt to dislodge the blockage in the extension line.The guide wire was able to pass through the extension line once some dried biological material was dislodged from the catheter.A blockage of this sort during use could lead to the over pressurization of the extension line that caused the defect.Performed per ifu statement "flush each lumen of catheter with sterile saline solution to establish patency and prime lumen(s)".The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user, "when used for pressure injection of contrast media, do not exceed the maximum indicated flow rate for each catheter lumen.The maximum pressure of power injector equipment used with pressure injectable cvc may not exceed 400 psi".The ifu also states, "only utilize catheters indicated for high pressure injection applications for such applications.Utilizing catheters not indicated for high pressure applications can result in inter-lumen crossover or rupture with potential for injury".The report of a damaged juncture hub was confirmed through complaint investigation.Visual analysis revealed that the juncture hub contained a hole/leak and the material around the hole was blown outwards , which is consistent with damage resulting from over-pressurization of the catheter during use.The catheter met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.A blockage caused by biological material was observed in the proximal extension line , which may have led to over pressurization of the extension line.After the blockage was dislodged, the catheter met all relevant functional requirements.Based on the customer report and the damage observed , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI CVC KIT: 4-L 8.5FR X 16CM 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: 14196661
• Report Number: 9680794-2022-00246
• Device Sequence Number: 14573182
• Product Code: FOZ
• UDI-Device Identifier: 10801902131468
• UDI-Public: 10801902131468
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 04/01/2022

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 Model Number: IPN904985
• Device Catalogue Number: ASK-42854-PMM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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