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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PARACENTESIS KIT; KIT SURGICAL INSTRUMENT DISPOS
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ARROW INTERNATIONAL INC. ARROW PARACENTESIS KIT; KIT SURGICAL INSTRUMENT DISPOS Back to Search Results
Catalog Number AK-00376
Device Problems Crack (1135); Fluid/Blood Leak (1250); Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The doctor performed a bedside thoracentesis.Upon inserting 8fr catheter with 3 way stopcock, blood/pleural fluid was leaking from a crack in hub of catheter.This leak prevented adequate suction for procedure to be performed effectively and efficiently.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one paracentesis kit lidstock for evaluation.Visual inspections of the stopcock could not be performed as no stopcock was returned.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit instructs the user, "attach male luer end of syringe tubing (included) to stopcock side port on catheter device.Ensure that the drainage outlet located at the bottom of the bag is in the closed position.Insert large connector firmly into drainage bag.Turn stopcock handle toward valve to open side port.Fluid can now be removed by gently moving syringe piston in and out, in a pumping motion." the customer report of stopcock leaking during use could not be confirmed by complaint investigation because the stopcock was not returned.A device history record review was performed with no relevant findings to suggest a manufacturing related issue.The root cause could not be determined without the stopcock.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
The doctor performed a bedside thoracentesis.Upon inserting 8fr catheter with 3 way stopcock, blood/pleural fluid was leaking from a crack in hub of catheter.This leak prevented adequate suction for procedure to be performed effectively and efficiently.
 
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Brand Name
ARROW PARACENTESIS KIT
Type of Device
KIT SURGICAL INSTRUMENT DISPOS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9911743
MDR Text Key187177592
Report Number9680794-2020-00172
Device Sequence Number1
Product Code KDD
Combination Product (y/n)N
PMA/PMN Number
K874063
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2022
Device Catalogue NumberAK-00376
Device Lot Number13F20A0192
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2020
Date Manufacturer Received05/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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