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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PNEUMOTHORAX KIT PROSTHESIS, ELBOW, CONSTRAINE

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ARROW INTERNATIONAL INC. ARROW PNEUMOTHORAX KIT PROSTHESIS, ELBOW, CONSTRAINE Back to Search Results
Catalog Number AK-01500
Device Problems Crack (1135); Leak/Splash (1354)
Patient Problems Pneumothorax (2012); No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Additional information requested from user facility. No additional information received at the time of this report.
 
Event Description
According to the medwatch ((b)(4)) a chest tube was inserted for diagnosis of pneumothorax. Chest x-ray confirmed good tube placement and decreased size of the pneumothorax. Later that evening a small amount of blood was noted coming through the pigtail tube. The next morning md ordered that a pleur evac be added to the end to see output. That evening, after the patient had taken a walk around the unit, a slight audible leak was noted when patient coughed. An hour later, the leak was noted whenever patient took a deep breath, the rn took down the dressing and the heimlich valve fell off. It was noted that the pigtail catheter tubing was cracked down the length of the tube. Chest x-ray showed increasing moderate to large pneumothorax. The chest tube was removed and a new one was placed with resolution of the pneumothorax. It was also reported the day after the chest tube was originally inserted there was bubbles in the water chamber whenever the patient spoke.
 
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Brand NameARROW PNEUMOTHORAX KIT
Type of DevicePROSTHESIS, ELBOW, CONSTRAINE
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
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
9194334854
MDR Report Key8390143
MDR Text Key138239208
Report Number9680794-2019-00063
Device Sequence Number1
Product Code JDC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K904021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAK-01500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/05/2019
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 Treatment Data
Date Received: 03/05/2019 Patient Sequence Number: 1
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