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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 8" (20 CM); CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 8" (20 CM); CATHETER PERCUTANEOUS Back to Search Results
Catalog Number ES-04701
Device Problems Difficult to Insert (1316); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the introducer needle had not been checked before the puncture, but after it was fixed and it was noted that the guide wire could not be inserted.After several insertion attempts, the introducer needle was pulled out for examination.Only then it was found with obvious indentation on the side of the introducer needle.
 
Event Description
It was reported that the introducer needle had not been checked before the puncture, but after it was fixed and it was noted that the guide wire could not be inserted.After several insertion attempts, the introducer needle was pulled out for examination.Only then it was found with obvious indentation on the side of the introducer needle.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned an introducer needle and a lidstock for analysis.Signs-of-use in the form of biological material was observed.Visual analysis revealed that the cannula of the introducer needle contained two dents and one scratch mark across the extrusion.Microscopic examination confirmed the dents.The appearance of the dents is consistent with the device becoming crushed.The dents in the cannula measured 36mm, 45mm, and 47mm from the cannula hub.The cannula length according to measurement a in the introducer needle graphic measured 68.5mm, which is within the specification limits of 67.13mm-68.91mm.The cannula inner diameter at the proximal end measured.041", which is within the specification limits of.041"-.043" per the cannula graphic.The cannula outer diameter (in an area that was not damaged) measured.050", which is within the specification limits of.050"-.051" per the cannula graphic.This indicates the wall thickness of the cannula is within specifications.A lab inventory guide wire with the same diameter as the one packaged within this kit was inserted through the cannula.Major resistance was observed when the guide wire reached the dents, which prevented the guide wire from passing.Manufacturing engineering was contacted as part of this complaint investigation.They stated that the introducer needles are 100% inspected for dents and scratch marks.They also indicated that it is more likely that this damage was created by needle holders during use on the patient.A device history record review was performed, and no relevant findings were identified.The report of a dented needle cannula was confirmed through complaint investigation.Visual and functional analysis revealed three dents on the needle cannula.The appearance of the defect appears consistent with damage due to crushing force.Product engineering was consulted and they indicated that the defect has the appearance of damage resulting from needle holders being used on the needle during use.The needle cannula met all relevant dimensional requirements, and a device history record review was performed with no relevant findings identified.Based on the customer report and engineering feedback, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC SET: 14 GA X 8" (20 CM)
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10303120
MDR Text Key199736076
Report Number3006425876-2020-00643
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date09/27/2022
Device Catalogue NumberES-04701
Device Lot Number71F17J0694
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2020
Date Manufacturer Received09/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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