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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 16 GA X 27 1/2IN; CATHETER INTRAVASCULAR THERAPE
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ARROW INTERNATIONAL LLC ARROW PICC SET: 16 GA X 27 1/2IN; CATHETER INTRAVASCULAR THERAPE Back to Search Results
Catalog Number AJ-01671
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2022
Event Type  malfunction  
Event Description
It was reported that the catheter was found cut during placement.Therefore, it was removed and replaced with a new one.On checking, the catheter was stretched and looked like it had been pulled.No patient harm was reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the catheter was found cut during placement.Therefore, it was removed and replaced with a new one.On checking, the catheter was stretched and looked like it had been pulled.No patient harm was reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one s-l catheter for analysis.Visual inspection of the catheter revealed that the catheter body was completely separated into two pieces.The points of separation for both pieces were rough and jagged.The catheter appears stretched and deformed at the points of separation, indicating it may have been pulled during use.The customer offered a potential explanation for how the damage occurred, indicating that the patient pushed the catheter repeatedly with their fingernail, and that it might have been cut by being pulled by the patient.The damage observed appeared consistent with this description.The overall length of the catheter was measured by adding the lengths of the two separate pieces.The catheter pieces measured 15 1/2" and 16", totaling 31 1/2", which is not within the specifications of 27 9/16" - 29 9/16" per product drawing.Since the catheter body appears stretched and pulled, it is being assumed that the catheter length is greater than the specification due to the stretching.The outer diameter of the catheter measured 0.06825", which is within the specification limits of 0.0655 - 0.0705" per the catheter body extrusion graphic.Functional inspection of the catheter could not be adequately performed due to the damage.A manual tug test confirmed the extension line was fully secured to its luer hub.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 instructions-for-use (ifu) provided with this kit warns the user, "do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the customer report of a cut/torn catheter was confirmed through complaint investigation of the returned sample.Visual inspection revealed the catheter was fully cut into two segments.The separation edges appeared rough and jagged, and the catheter appeared severely stretched at the point of separation.A device history record review based on sales history did not reveal any evidence to suggest a manufacturing related issue.Based on these circumstances, the report that the damage occurred during use, and the comments from the customer, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
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Brand Name
ARROW PICC SET: 16 GA X 27 1/2IN
Type of Device
CATHETER INTRAVASCULAR THERAPE
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 Key16011345
MDR Text Key306322988
Report Number9680794-2022-00788
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K042126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/30/2022
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 NumberAJ-01671
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/30/2022
Initial Date FDA Received12/19/2022
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received01/13/2023
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
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