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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAP
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ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAP Back to Search Results
Catalog Number CDC-42703-P1A
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/08/2022
Event Type  malfunction  
Event Description
It was reported the white port broke off from the tubing while indwelling in a patient.The catheter had been inserted on (b)(6) 2022.It was reported the catheter was removed since the patient's status improved.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).The customer provided one lidstock and a cvc catheter for analysis.Signs of use in the form of biological material were observed inside the extension lines.The separated proximal luer hub (white hub) was not returned for analysis.It was also noted that surgical tape was placed over the proximal extension line.This adhesive was removed with minor difficulty in order to analyze the point of separation.Visual analysis revealed that the proximal extension line was separated , resulting in the white luer hub to completely detach from the assembly.Visual analysis of the proximal extension line revealed that the extrusion wall appears stretched/narrow directly adjacent to the point of separation.Microscopic examination confirmed the separation and revealed that the separation edges were rough and jagged, which is a defect consistent with a known manufacturing issue; however, without the separation white luer hub also returned for analysis, this cannot be confirmed.Visual inspection of the separated luer hub could not be performed as it was not returned for analysis.The catheter body length from the juncture hub to the distal tip measured 166mm , which is within the specification limits of 157mm-177mm per the catheter product drawing.The proximal extension line outer diameter (at an area not affected by the narrowing/stretching) measured.0845", which is within the specification limits of.0840"-.0870" per the proximal extension line extrusion product drawing.The proximal extension line inner diameter directly at the point of separation measured.044", which is not within the specification limits of.055"-.059" per the proximal extension line extrusion product drawing; however, this is likely due to the narrowing/stretching of the extension line extrusion.The extension line was intentionally severed at a location more distal to the stretched section.The proximal extension line inner diameter was measured at this new separation point.The inner diameter measured.057", which is within the specification limits of.055"-.059" per the proximal extension line extrusion product drawing.Dimensional inspection of the separated luer hub could not be performed as it was not returned for analysis.A lab inventory syringe filled with water was attached to the distal and medial extension lines and flushed.The fluid exited out of the respective skive holes for each extension line.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen".A manual tug test confirmed that the medial and distal luer hubs were secure to their respective extension lines.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 apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of an extension line/luer hub separation was confirmed through complaint investigation.Visual analysis revealed that the proximal extension line had separated causing the white luer hub to completely detach from the assembly.The separated luer hub was not returned for analysis to confirm if there is any portion of the extension line still molded to the luer hub.Aside from this, it was noted that the proximal extension line inner diameter at the point of separation was not within the specification limits; however, it was determined this was due to the stretching of the extrusion.All other relevant dimensional and functional requirements were met, and a device history record review was performed based on sales history with no relevant findings.Based on the customer report and the sample received, the root cause cannot be determined without the separated white luer hub also returned.Additionally, it is unknown what caused the stretching of the proximal extension line.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
It was reported the white port broke off from the tubing while indwelling in a patient.The catheter had been inserted on (b)(6) 2022.It was reported the catheter was removed since the patient's status improved.No patient harm reported.The patient's condition is reported as fine.
 
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Brand Name
ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 16 CM
Type of Device
CATHETER INTRAVASCULAR THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key15325276
MDR Text Key305254498
Report Number9680794-2022-00515
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071538
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/08/2022
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 Catalogue NumberCDC-42703-P1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 08/08/2022
Initial Date FDA Received08/30/2022
Supplement Dates Manufacturer Received09/23/2022
Supplement Dates FDA Received09/26/2022
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.
Patient SexFemale
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