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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC: 1-L 4FR X 40CM 80CM HNIT WIRE; CATHETER,INTRAVASCULAR,THERAPE
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ARROW INTERNATIONAL LLC ARROW PI PICC: 1-L 4FR X 40CM 80CM HNIT WIRE; CATHETER,INTRAVASCULAR,THERAPE Back to Search Results
Catalog Number PR-34041-NM
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/17/2023
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported "after placement of the catheter, the piece of the cut catheter was found next to the patient bed.Therefore, the catheter was replaced with a new one.No harm to the patient was reported." the patient's condition was reported to be fine.
 
Manufacturer Narrative
(b)(4).The customer provided one photo for evaluation.The image shows a picc catheter that appears stretched and torn.The customer also returned one s-l picc for analysis.Visual inspection revealed that the catheter was fully cut into two pieces at the level of the clamp catheter/clamp fastener.Both separation edges are rough and jagged.The catheter appeared stretched and deformed at the points of separation, and the markings near the separation points are stretched/deformed.The appearance of the damage indicates that the catheter was subjected to undue force.The catheter pieces measured 13 3/4" and 4 1/2", totaling 18 1/4", (b)(4).The markings on both segments of the catheter appeared to line up according to specification.The shorter piece of the catheter was observed to be significantly stretched, which corresponds to the out of spec measurement.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 the 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 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.Minimize catheter manipulation throughout procedure to maintain proper catheter tip position." 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 stretched at the point of separation.The catheter met all relevant dimensional requirements, and a device history record review based on sales history did not reveal any evidence to suggest a manufacturing related issue.Based on the customer report that the catheter was damaged during use and the appearance of the damage, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
It was reported "after placement of the catheter, the piece of the cut catheter was found next to the patient bed.Therefore, the catheter was replaced with a new one.No harm to the patient was reported." the patient's condition was reported to be fine.
 
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Brand Name
ARROW PI PICC: 1-L 4FR X 40CM 80CM HNIT WIRE
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 Key16387420
MDR Text Key309759999
Report Number9680794-2023-00070
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K113277
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 01/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberPR-34041-NM
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/06/2023
Is the Reporter a Health Professional? No
Date Manufacturer Received03/11/2023
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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