MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW THORACENTESIS KIT; CATHETER AND TIP SUCTION

Catalog Number	AK-01000
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "after the catheter was placed in the patients pleural space the physician noticed there was an increasing leak coming from the device.The physician with assistance was able to keep the procedure going.The physician needed to have assistance by having someone withdraw pleural fluid with the 50cc syringe while he held the broken stopcock piece together.He was able to complete the procedure but since the system was not totally intact he was unable to send the fluid for cultures.The patient did not appear to have any complications with the procedure.The physician explained the situation to the patient and given follow up instructions.".
Additional Manufacturer Narrative
(b)(4).The customer provided one image for analysis.The image shows the separation of the stopcock.The customer returned one thoracentesis device for analysis.Signs of use in the form of biological material were observed inside the stopcock.Visual analysis revealed that the proximal end of the stopcock was separated.Multiple scratches and damage were observed on the separated portion of the stopcock.Microscopic examination confirmed the damage and revealed that the edges of the separation were rough.A manual tug test confirmed that the connected portion of the stopcock was secure within the catheter hub.R & d was consulted as a part of this complaint investigation.They stated that multiple factors or a combination of factors could result in the observed damage.Excessive force applied during the assembly process which would result in eventual environmental stress cracking (esc) as well as temperatures and conditions experienced during transportation could cause the damage.Additionally, without the rest of the components returned for analysis, it cannot be confirmed if damage was incurred during shipping/storage.A device history record review was performed, and no relevant findings were identified.The report that a stopcock cracked/leaked was confirmed through complaint investigation.The stopcock separated towards the proximal end and multiple scratches were observed on the separated portion.R & d was consulted, and they stated that various potential causes for the observed damage, including excessive force applied during assembly and transportation conditions.Based on the customer report, sample received , and comments from r & d, the potential root cause cannot be determined at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported "after the catheter was placed in the patients pleural space the physician noticed there was an increasing leak coming from the device.The physician with assistance was able to keep the procedure going.The physician needed to have assistance by having someone withdraw pleural fluid with the 50cc syringe while he held the broken stopcock piece together.He was able to complete the procedure but since the system was not totally intact he was unable to send the fluid for cultures.The patient did not appear to have any complications with the procedure.The physician explained the situation to the patient and given follow up instructions.".

• Brand Name: ARROW THORACENTESIS KIT
• Common Device Name: CATHETER AND TIP SUCTION
• 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: 17537701
• Report Number: 9680794-2023-00576
• Device Sequence Number: 20392436
• Product Code: JOL
• UDI-Device Identifier: 30801902120121
• UDI-Public: 30801902120121
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K870572
• 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): 07/21/2023

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 Expiration Date: 11/30/2024
• Device Catalogue Number: AK-01000
• Device Lot Number: 13F22D0459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 08/12/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2022
• 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