MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN033056
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "a (b)(6) year-old female patient with a right internal jugular tunnel catheter inserted since 07 may 2019 [had] a ct angiogram performed on (b)(6) 2021.A hemodialysis catheter was necessary to inject a contrast product.The contrast product was injected using an automatic injector (200 psi) on the red line without unclamping the clamp of the catheter.The degradation of the extension line of the central venous hemodialysis catheter required its change".No injury or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.
Event or Problem Description
It was reported that: "a 66-year-old female patient with a right internal jugular tunnel catheter inserted since (b)(6) 2019 [had] a ct angiogram performed on (b)(6) 2021.A hemodialysis catheter was necessary to inject a contrast product.The contrast product was injected using an automatic injector (200 psi) on the red line without unclamping the clamp of the catheter.The degradation of the extension line of the central venous hemodialysis catheter required its change".No injury or consequence reported.Patient condition reported as "fine".
Event or Problem Description
It was reported that: "a 66-year-old female patient with a right internal jugular tunnel catheter inserted since (b)(6) 2019 [had] a ct angiogram performed on (b)(6) 2021.A hemodialysis catheter was necessary to inject a contrast product.The contrast product was injected using an automatic injector (200 psi) on the red line without unclamping the clamp of the catheter.The degradation of the extension line of the central venous hemodialysis catheter required its change".No injury or consequence reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one hemodialysis catheter for analysis.Signs-of-use in the form of biological material were observed.Visual analysis revealed that the arterial extension line had ballooned near the arterial luer hub.Microscopic examination confirmed the damage.No other defects or anomalies were observed.The arterial extension line outer diameter in an area not affected by the ballooning measured 0.188" which is within the specification limits of 0.185"-0.191" per the arterial extension line extrusion graphic.The arterial extension line inner diameter measured 0.122" which is within the specification limits of 0.120"-0.126" per the arterial extension line extrusion graphic.A manual tug test confirmed that the arterial and venous luer hubs were secured to their extension lines.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with this kit warns the user, "open catheter clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the report of a ballooned extension line was confirmed through complaint investigation.Visual analysis revealed that the arterial extension line was ballooned near the arterial luer hub.The arterial extension line met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.An in-service was requested to further educate the customer on this product's intended usage.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 27 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12177688
• Report Number: 9680794-2021-00337
• Device Sequence Number: 13860923
• Product Code: MSD
• UDI-Device Identifier: 00801902043931
• UDI-Public: 00801902043931
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/21/2021

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: 12/31/2020
• Device Model Number: IPN033056
• Device Catalogue Number: CS-15322-VSP
• Device Lot Number: 23F17M0425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 06/21/2021
• Supplement Date Received by Manufacturer: 08/05/2021; 08/10/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/05/2021; 08/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.
• Patient Age: 66 YR