MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW DRAINAGE KIT; CATHETER IRRIGATION

Catalog Number AK-01601

Device Problem Mechanical Problem (1384)

Patient Problem Pneumothorax (2012)

Event Date 02/23/2022

Event Type  Injury  

Event Description

Physician reports the side port cap gets "unscrewed and/or the clamp comes undone causing a pneumothorax".It was reported there was no cap on the end and clamp was present but unclamped involving a single patient.The chest tube was clamped once it was realized the side port was open.The pneumothorax resolved in follow-up x-ray the next morning after clamping the side port.It was reported the issue did not lead to patient decompensation or injury.This report captures the clamp coming undone.The issue with the side port cap coming off is captured in report # 9680794-2022-00176.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).Additional information received from customer: "the devices in question are not defective.We did not save the drains after removal because the problem is operator error.The problem is the side port that is unique to those drains.It is the only chest drain that has a side port and our nursing staff was not educated to check the port for occlusion as part of their standard assessments.That education has been undertaken and will be ongoing." the report has been updated to reflect an adverse event (pneumothorax) and not a product problem as originally reported.Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.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 Description

Physician reports the side port cap gets "unscrewed and/or the clamp comes undone causing a pneumothorax".It was reported there was no cap on the end and clamp was present but unclamped involving a single patient.The chest tube was clamped once it was realized the side port was open.The pneumothorax resolved in follow-up x-ray the next morning after clamping the side port.It was reported the issue did not lead to patient decompensaion or injury.This report captures the clamp coming undone.The issue with the side port cap coming off is captured in report # 9680794-2022-00176.

• Brand Name: ARROW DRAINAGE KIT
• Type of Device: CATHETER IRRIGATION
• 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: 13894684
• MDR Text Key: 287895196
• Report Number: 9680794-2022-00175
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K895516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-01601
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 04/18/2022
• Supplement Dates FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other