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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE
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ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number CS-45854-E
Device Problem Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
The complaint is reported as: "nurse noted hole in medial (blue) lumen line when changing blood soaked cvc dressing.Hole is a semi circle and does not transect through the line.Day prior the pulmonary artery catheter was removed so potentially this was caused by the suture removal.However, time lines do not match up.Faulty cvc removed." no patient harm reported.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one, 4-l cvc catheter for analysis.Signs-of-use in the form of biological material was observed inside the extension lines.After failing functional testing (see below), a hole was observed on the medial 2 (blue hub) extension line.The appearance of the hole is semi-circular and seems consistent with damage due to contact with sharps.Microscopic examination confirmed the damage and revealed that the edges were smooth and uniform.This further supports that contact with sharps caused or contributed to this event.The hole in the medial 2 extension line measured 13mm from the juncture hub.The catheter body from the juncture hub to the distal tip measured 217mm which is within the specification limits of 207mm-227mm per the catheter graphic.The medial 2 (blue hub) extension line outer diameter measured 2.195mm which is within the specification limits of 2.130mm-2.210mm per the medial 2 extension line extrusion graphic.The medial 2 (blue hub) extension line inner diameter measured 1.473mm which is within the specification limits of 1.420mm-1.500mm per the medial 2 extension line extrusion graphic.A lab inventory syringe filled with water was attached to the medial 2 (blue hub) extension line.The syringe was compressed, and water was observed leaking out of a hole on the extension line.Performed per ifu statement "check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed".No other leaks or defects were observed when flushing the other extension lines.A manual tug test confirmed that the extension lines were secure within the respective luer hubs.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations".The report of a leaking extension line was confirmed through complaint investigation.Visual and functional testing revealed that the medial 2 (blue hub) extension line contained a hole directly adjacent to the juncture hub.The appearance of the hole seems consistent with damage due to contact with sharps.Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review was performed based on a potential lot with no relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The complaint is reported as: "nurse noted hole in medial (blue) lumen line when changing blood soaked cvc dressing.Hole is a semi circle and does not transect through the line.Day prior the pulmonary artery catheter was removed so potentially this was caused by the suture removal.However, time lines do not match up.Faulty cvc removed." no patient harm reported.
 
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Brand Name
ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM
Type of Device
CATHETER INTRAVASCULAR THERAPE
MDR Report Key12484707
MDR Text Key271799109
Report Number3006425876-2021-00864
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K993691
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/31/2021
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 Catalogue NumberCS-45854-E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2021
Initial Date Manufacturer Received 08/31/2021
Initial Date FDA Received09/16/2021
Supplement Dates Manufacturer Received10/26/2021
Supplement Dates FDA Received10/26/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
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