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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER
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ARROW INTERNATIONAL INC. ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM; MIDLINE CATHETER Back to Search Results
Catalog Number PR-41541-BAS
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: there is a leak at the junction of the extension line and the hub.Leak during flush of medication.They removed the mid-line and patient received atb in pills.It is reported that therapy was delayed.Patient is fine.
 
Event Description
The customer reports: there is a leak at the junction of the extension line and the hub.Leak during flush of medication.They removed the mid-line and patient received atb in pills.It is reported that therapy was delayed.Patient is fine.
 
Manufacturer Narrative
Qn#(b)(4).The customer returned one, single-lumen midline catheter for analysis.Signs-of-use in the form of biological material was observed on the luer hub.Visual analysis of the sample revealed that the catheter body was severed just below the 12cm mark.The edges of the point of separation appears smooth indicating that the customer intentionally cut the catheter body.The separated portion was not returned for analysis.No other defects or anomalies were observed.The extension line length from the luer hub to the juncture hub measured 1.64", which is consistent with the nominal value of 1.63" per the midline catheter product drawing.The extension line outer diameter measured.093", which is within the specification limits of.093"-.097" per the extension line extrusion product drawing.The extension line inner diameter measured.057", which is within the specification limits of.055"-.059" per the extension line extrusion product drawing.A leak test was performed on the catheter.With the distal end of the catheter body occluded, water was injected through the catheter at 45psi for 30 seconds.No leaks were observed on the extension line or the catheter body.A manual tug test confirmed that the extension line was secure to the luer hub and the juncture hub.A device history record review was performed with no relevant findings to suggest a manufacturing related cause.The ifu provided with the kit warns the user, "use only lumen(s) labeled 'pressure injectable' for pressure injection to reduce risk of catheter failure and/or patient complications." the ifu also warns, "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 report of an extension line leak could not be confirmed through complaint investigation.Visual analysis did not reveal any holes on the extension line.Additionally, the catheter met all relevant dimensional and functional requirements.A leak test was performed and no leaks were observed.A device history record review did not reveal any reliant findings to suggest a manufacturing related cause.Based on the sample received and the report from the customer, no problem could be found with the returned sample.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW AGBA PI MIDLINE 1-L: 4.5FR X 15CM
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8850451
MDR Text Key177206678
Report Number9680794-2019-00286
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,foreig
Type of Report Initial,Followup
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date08/31/2020
Device Catalogue NumberPR-41541-BAS
Device Lot Number13F18J0153
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/29/2019
Date Manufacturer Received09/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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