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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROWGARD BLUE PLUS PRESSURE INJECTABLE QUAD LUMEN CVC; QUAD LUMEN CENTRAL VENOUS CATHETER
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ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROWGARD BLUE PLUS PRESSURE INJECTABLE QUAD LUMEN CVC; QUAD LUMEN CENTRAL VENOUS CATHETER Back to Search Results
Model Number ASK-42854-PMGH
Device Problem Insufficient Information (3190)
Patient Problems Sepsis (2067); Skin Discoloration (2074); Tissue Damage (2104)
Event Date 06/24/2014
Event Type  Injury  
Event Description
The patient was admitted with sepsis and required placement of a 4 lumen, 16 cm sub-clavian central access for vasopressors and anti-arthymics.Within 36 hours of placement, the patient developed skin discoloration at the insertion site.This progressed to tissue breakdown that required surgical debridement and grafting.
 
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Brand Name
ARROWGARD BLUE PLUS PRESSURE INJECTABLE QUAD LUMEN CVC
Type of Device
QUAD LUMEN CENTRAL VENOUS CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
2400 bernville road
reading PA 19605
MDR Report Key5013998
MDR Text Key23447605
Report Number5013998
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Report Date 10/03/2014,07/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2015
Is this an Adverse Event Report? Yes
Device Operator Nurse
Device Model NumberASK-42854-PMGH
Device Catalogue NumberASK-42854-PMGH
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/03/2014
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer10/03/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
CARDIAC DRUGS
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age66 YR
Patient Weight98
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