MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2022

Event Type  malfunction  

Manufacturer Narrative

Qn #(b)(4).Associated mdr#'s 3006425876-2022-00936.

Event Description

It was reported during the first insertion, the junction between the ars (arrow raulerson syringe) and introducer needle "loosed easily".The same situation happened again during the second insertion.The third time the insertion succeeded.It was reported the device was replaced and there was no delay in therapy or patient complications.No medical intervention was required.Additional information received (b)(6) 2022 that the patient was deceased."the patient was in critical condition prior to use the devices.The patient death was not caused by complaint devices." additional information was requested, but was not available at the time of this report.

Event Description

It was reported during the first insertion, the junction between the ars (arrow raulerson syringe) and introducer needle "loosed easily".The same situation happened again during the second insertion.The third time the insertion succeeded.It was reported the device was replaced and there was no delay in therapy or patient complications.No medical intervention was required.Additional information received 29sep2022 that the patient was deceased."the patient was in critical condition prior to use the devices.The patient death was not caused by complaint devices.".Additional information was requested, but was not available at the time of this report.

Manufacturer Narrative

(b)(4).Associated mdr#'s 3006425876-2022-00936.The customer returned one arrow raulerson syringe (ars)/introducer needle subassembly and a lidstock for analysis.Signs of use in the form of biological material was observed.Visual inspection did not reveal any defects or anomalies.There were no cracks observed in the needle hub.The ars tip appeared normal.The connection between the returned syringe and needle was compared with another ars syringe and introducer needle from lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.The returned needle appears to be fitting loosely on both the returned syringe and the lab inventory syringe.The hub of the needle was tested with the male luer gauge and was not within the specified range.This indicates that the luer was nonconforming per iso 594-1:1986.The ars and needle involved with this complaint was sent to the wyomissing facility for additional testing and ftir & swm/eds analysis.Ftir & swm/eds analysis revealed a build-up of silicone lubricant on the surface of the ars tip and the needle hub.Further discussions between r & d and manufacturing revealed that the silicone application process is a mechanical setup based on visual criteria.A device history record review was performed, and no relevant finding was identified.The ifu provided with the kit informs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The report of a syringe/needle connection issue was confirmed through complaint investigation.Visual analysis did not reveal any obvious defects or anomalies; however, functional testing revealed that the connection was loose.The sample was sent to r & d for additional analysis.They discovered a build-up of silicone on the ars tip and needle hub surfaces.Based on the customer report and the comments from r & d, the root cause cannot be determined and further analysis is warranted.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

Manufacturer Narrative

(b)(4).Associated mdr#'s 3006425876-2022-00936 and 3006425876-2022-00935.Corrected data: the customer returned one, opened cvc kit for analysis.The ars and 18 ga introducer needle will be analyzed as part of this investigation.Signs of use were observed on the needle hub.Visual inspection did not reveal any defects or anomalies.There were no cracks observed in the needle hub.The ars tip appeared normal.The connection between the returned syringe and needle was compared with another ars syringe and introducer needle from lab inventory.The returned ars syringe was tested with a lab inventory needle, and the returned needle was tested with a lab inventory ars syringe.The returned needle appears to be fitting loosely on both the returned syringe and the lab inventory syringe.The hub of the needle was tested with the male luer gauge and was within the specified range.This indicates that the luer was conforming per iso 80369-7.The ars and needle involved with this complaint was sent to the wyomissing facility for additional testing and ftir & swm/eds analysis.Ftir & swm/eds analysis revealed a build-up of silicone lubricant on the surface of the ars tip and the needle hub.Further discussions between r & d and manufacturing revealed that the silicone application process is a mechanical setup based on visual criteria.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "insert introducer needle or catheter/needle with attached syringe or arrow raulerson syringe (where provided) into vein and aspirate".The report of a syringe/needle connection issue was confirmed through complaint investigation.Visual analysis did not reveal any obvious defects or anomalies; however, functional testing revealed that the connection was loose.The sample was sent to r & d for additional analysis.They discovered a build-up of silicone on the ars tip and needle hub surfaces, which is not intended and likely occurred during manufacturing.Based on the customer report and the comments from r & d, the root cause cannot be determined and warrants further evaluation.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported during the first insertion, the junction between the ars (arrow raulerson syringe) and introducer needle "loosed easily".The same situation happened again during the second insertion.The third time the insertion succeeded.It was reported the device was replaced and there was no delay in therapy or patient complications.No medical intervention was required.Additional information received on 29sep2022 that the patient was deceased."the patient was in critical condition prior to use the devices.The patient death was not caused by complaint devices." additional information was requested, but was not available at the time of this report.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 15666295
• MDR Text Key: 306629760
• Report Number: 3006425876-2022-00935
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: CS-25703-E
• Device Lot Number: 71F22B1718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED; NOT REPORTED