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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER
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ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER Back to Search Results
Catalog Number CDC-41541-MPK1A
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reports that there was a "tear" in the clear tubing (pigtail outside the patient).The patient condition is reported as "fine".There was no patient complication, injury or consequence.Therapy was not delayed/interrupted.
 
Event Description
Customer reports that there was a "tear" in the clear tubing (pigtail outside the patient).The patient condition is reported as "fine".There was no patient complication, injury or consequence.Therapy was not delayed/"interrupted.".
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one single lumen midline catheter for evaluation.The sample contained obvious signs of use in the form of biological material in the extension line and on the catheter body.Visual inspection revealed a small hole in the distal extension line adjacent to the luer hub.The damage is consistent with a molding issue.The total length of the catheter body was measured to be 6.625" which is within specifications of 6.25"-6.75" per coated catheter product drawing.The outer diameter of the distal lumen measured to be 0.09535" which is within specifications of 0.093"-0.097" per distal extension line extrusion product drawing.The inner diameter of the distal extension line measured to be 0.057", which is within specifications of 0.055"-0.059" per distal extension line extrusion product drawing.This indicates that the wall thickness measured as expected.The catheter was flushed using a lab inventory syringe to ensure there were no blockages.The distal end was then clamped, and a water-filled lab inventory syringe pressurized the distal line.A leak was observed near the luer hub when pressurized.A manual tug test confirmed the distal extension line was fully secured within the luer hub.A device history record review was performed, and no relevant findings were identified.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.Open slide clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure." the customer report of an extension line leak was confirmed through complaint investigation of the returned sample.The distal extension line contained one hole/separation adjacent to the luer hub.The appearance of the damage was consistent with a manufacturing related root cause.A non-conformance has been initiated to further investigate this molding issue.Teleflex will continue to monitor and trend for complaints of this nature.
 
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Brand Name
ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10096529
MDR Text Key196310270
Report Number1036844-2020-00163
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
PMA/PMN Number
K161313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2021
Device Catalogue NumberCDC-41541-MPK1A
Device Lot Number23F19L0388
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Date Manufacturer Received06/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age72 YR
Patient Weight106
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