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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTL., INC. THORACENTESIS KIT; THORACIC CATHETER PRODUCTS
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ARROW INTL., INC. THORACENTESIS KIT; THORACIC CATHETER PRODUCTS Back to Search Results
Catalog Number AK-01000
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/06/2015
Event Type  malfunction  
Event Description
It was reported the clinician checked the valve prior to insertion and it did not engage.As a result, another kit was opened.
 
Manufacturer Narrative
Qn#: (b)(4).This report is for the first of two consecutive product issues.The second has been reported under mdr# 1036844-2015-00228.No sample will be returned for evaluation.
 
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Brand Name
THORACENTESIS KIT
Type of Device
THORACIC CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTL., INC.
reading PA
Manufacturer (Section G)
ARROW INTL., INC.
312 commerce pl.
asheboro NC 27203
Manufacturer Contact
john george, specialist
2400 bernville rd
reading, PA 19605
MDR Report Key4810690
MDR Text Key5836213
Report Number1036844-2015-00227
Device Sequence Number1
Product Code JOL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K870572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 05/06/2015
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
Device Operator Health Professional
Device Expiration Date02/28/2017
Device Catalogue NumberAK-01000
Device Lot Number23F14J0116
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/06/2015
Initial Date FDA Received06/01/2015
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/01/2014
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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