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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 3-L 7 FR X 12"; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 3-L 7 FR X 12"; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SA-14703-J
Device Problem Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/24/2019
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The customer reports: after catheter placement, when the user aspirated blood through distal lumen with the syringe in order to check lumen placement, air was confirmed in the aspirated blood.Therefore, the inserted catheter was removed, and another competitor's cv catheter was inserted instead.No patient injuries/complications occurred associated with this failure.No additional surgery/medical intervention needed.
 
Event Description
The customer reports: after catheter placement, when the user aspirated blood through distal lumen with the syringe in order to check lumen placement, air was confirmed in the aspirated blood.Therefore, the inserted catheter was removed, and another competitor's cv catheter was inserted instead.No patient injuries/complications occurred associated with this failure.No additional surgery/medical intervention needed.
 
Manufacturer Narrative
(b)(4).The customer returned one cvc catheter for analysis.Signs-of-use in the form of biological material was observed inside the distal extension line.Visual analysis of the catheter did not reveal any defects or anomalies.The distal extension line length from the luer hub to the juncture hub measured 85mm, which is within the specification limits of 84.90mm-85.10mm per the catheter graphic.The distal extension line outer diameter measured 2.14mm, which is within the specification limits of 2.13mm-2.21mm per the distal extension line extrusion graphic.The distal extension line inner diameter measured 1.448mm, which is within the specification limits of 1.42mm-1.50mm per the distal extension line extrusion graphic.All three extension lines of the returned catheter were tested for liquid leakage.The catheter was attached to a leak tester, the distal end was occluded, and the leak tester was turned to 300 kpa for 30 seconds.No leaks or air were detected from any region of the catheter, including the extension lines; therefore, the sample passed functional testing.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing related cause.The ifu provided with the kit informs the user, "to minimize the risk of damage to pigtails from excessive pressure, each clamp must be opened prior to infusing through that lumen." the report of a leaking extension line could not be confirmed through complaint investigation.Visual analysis did not reveal any defects or anomalies.The catheter also met all relevant dimensional and passed functional leak testing.Additionally , a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, no problem was found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW MULTI-LUMEN CVC KIT: 3-L 7 FR X 12"
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9555078
MDR Text Key179717870
Report Number3006425876-2020-00061
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/24/2019
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 No Information
Device Expiration Date03/31/2021
Device Catalogue NumberSA-14703-J
Device Lot Number71F19C2682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2020
Initial Date Manufacturer Received 12/24/2019
Initial Date FDA Received01/06/2020
Supplement Dates Manufacturer Received02/05/2020
Supplement Dates FDA Received02/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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