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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. PNEUMOTHORAX KIT; EMERGENCY/TRAUMA PRODUCTS
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ARROW INTL., INC. PNEUMOTHORAX KIT; EMERGENCY/TRAUMA PRODUCTS Back to Search Results
Catalog Number CA-01500
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/07/2014
Event Type  malfunction  
Event Description
It was reported the procedure was being performed in the emergency department.During insertion, the physician experienced difficulty with the plastic tip "bunching".They made a skin cut preceding the insertion.As a result, another kit was opened and placed successfully.There were no delays in treatment and no patient deaths or complications reported.
 
Manufacturer Narrative
(b)(4).The device will not be returned.
 
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Brand Name
PNEUMOTHORAX KIT
Type of Device
EMERGENCY/TRAUMA PRODUCTS
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
asheboro NC 27203
Manufacturer Contact
jody cadd, sr, ras
2400 bernville road
reading, PA 19605
6103780131
MDR Report Key3894372
MDR Text Key4539986
Report Number1036844-2014-00067
Device Sequence Number1
Product Code JOL
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K883905
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 02/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberCA-01500
Device Lot NumberRF3013616
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/11/2014
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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