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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATION, INC. A SUBSIDIARY OF TELFLEX INC. ARROWGARD 7 FR. 3 LUMEN 20 CM, 0.32 GUIDEWIRE TRIPLE LUMEN CATHETER

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ARROW INTERNATION, INC. A SUBSIDIARY OF TELFLEX INC. ARROWGARD 7 FR. 3 LUMEN 20 CM, 0.32 GUIDEWIRE TRIPLE LUMEN CATHETER Back to Search Results
Model Number 010801902119206
Device Problem Unraveled Material (1664)
Patient Problem Pneumothorax (2012)
Event Date 01/15/2017
Event Type  Injury  
Event Description
Pt came to hospital er with sepsis and hypotension. Required iv central line. Central line kit had defective wire that would unravel when trying to advance catheter over wire. Occurred 3 times before choosing a different arrowgard kit with new lot number, the fourth kit was able to be inserted. Dr. (b)(6) placed central line using kit from omni cell. #ak-45703 cdc. Packaging from same company that we have used in the past, but appears different color. (this package with black writing, old with blue. ) recent change per spd. Guide wire inserted. Dr. (b)(6) unable to thread sheath. When guide wire removed. Guide wire had unraveled becoming too weak to thread sheath and causing there to be a sharp end that was bent sideways during removal. This happened a total of three times with the kits with black writing. A blue kit was found and line was inserted without complications. Pt suffered a pneumothorax. Required insertion of a chest tube and prolonged hospitalization to recover.
 
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Brand NameARROWGARD 7 FR. 3 LUMEN 20 CM, 0.32 GUIDEWIRE
Type of DeviceTRIPLE LUMEN CATHETER
Manufacturer (Section D)
ARROW INTERNATION, INC. A SUBSIDIARY OF TELFLEX INC.
2400 bernville rd.
reading PA 19605
MDR Report Key6512668
MDR Text Key73568136
Report Number6512668
Device Sequence Number1
Product Code FOZ
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Model Number010801902119206
Device Catalogue Number0180630
Device Lot Number13F16M0015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/17/2017
Event Location Hospital
Date Report to Manufacturer01/19/2017
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/12/2017 Patient Sequence Number: 1
Treatment
PLACEMENT PNEUMO THORAX FROM (B)(6) 2017 TO...; REQUIRED CHEST TUBE FOR TREATMENT OF POST-LINE
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