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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MIDLINE CATHETERIZATION KIT; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW MIDLINE CATHETERIZATION KIT; CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN038071
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The product (catalog# uk-00320-rdeh1) is not intended for sale in the us.Similar product/component sold in the us.
 
Event Description
It was reported that midline catheter was replaced after two weeks of insertion.A fracture in the clear tubing was detected.The product was used in accordance with the ifu and checked before use.Anatomical insertion site was the upper arm.The device was removed in its entirety and replaced successfully with another line.Therapy was delayed but no harm caused to patient.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one single-lumen catheter for evaluation.After the sample failed functional testing, the extension line was microscopically examined.Significant signs of adhesive material were found on the lumen.A small slit was also detected, causing the leak.The slit was smooth and straight, indicating contact with a sharp object (scissors, scalpel, needle, etc.) caused the damage.The total length of the returned catheter measured to be 207 mm which is within specifications of 200-212.8 mm per product drawing.The distal lumen contained one slit 3 mm from proximal end of the juncture hub.The inner diameter of the returned lumen measured to be 0.058" which is within specifications of 0.055-0.059" per product drawing.The outer diameter of the returned lumen measured to be 0.087" which is within specifications of 0.084-0.088" per product drawing.This indicates that the wall thickness measured within specifications.The catheter was flushed using a water-filled lab inventory syringe.Water leaked from a small slit in the lumen.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the customer report of an extension line leak was confirmed by complaint investigation of the returned sample.The distal lumen contained one small slit with damage consistent with coming in contact with a sharp object.The sample passed all relevant dimensional inspection and a device history record review was performed with no relevant findings.Based on the condition of the sample received and the report that the catheter was placed for 2 weeks prior to defect, unintentional user error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
 
Event Description
It was reported that midline catheter was replaced after two weeks of insertion.A fracture in the clear tubing was detected.The product was used in accordance with the ifu and checked before use.Anatomical insertion site was the upper arm.The device was removed in its entirety and replaced successfully with another line.Therapy was delayed but no harm caused to patient.
 
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Brand Name
ARROW MIDLINE CATHETERIZATION KIT
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10442151
MDR Text Key204009524
Report Number3006425876-2020-00738
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 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/11/2021
Device Model NumberIPN038071
Device Catalogue NumberUK-00320-RDEH1
Device Lot Number71F19F0141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2020
Date Manufacturer Received09/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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