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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL LLC ARROW DRAINAGE KIT; CATHETER IRRIGATION Back to Search Results
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.
 
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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 Key13894684
MDR Text Key287895196
Report Number9680794-2022-00175
Device Sequence Number1
Product Code GBX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K895516
Number of Events Reported1
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 NumberAK-01601
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/01/2022
Initial Date FDA Received03/24/2022
Supplement Dates Manufacturer Received04/18/2022
Supplement Dates FDA Received04/19/2022
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 Number1
Treatment
NOT REPORTED; NOT REPORTED
Patient Outcome(s) Other;
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