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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 2-L 8 FR X 6" CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN CVC KIT: 2-L 8 FR X 6" CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CDC-42802-P1A
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/09/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A representative sample was sent for evaluation.
 
Event Description
The customer alleges that the second site securement device was placed correctly and sutured. After a few minutes, the clamp away from the insertion site did not hold and came apart and the catheter pulled out. No patient injury or consequence reported.
 
Manufacturer Narrative
(b)(4). The customer returned a catheter clamp (green) and a clamp fastener (blue) for evaluation. It was reported that the catheter clamp/clamp fastener were a representative sample and not the complaint sample. The inner diameter of the clamp could not be measured since the clamp material is pliable. When assembled, the largest outer diameter (od) pin gauge that would pass through the clamp assembly without resistance was 0. 074". The returned clamp is in a kit that contains an 8fr catheter. Since the catheter was not returned, an 8 fr catheter from lab inventory with an od of 0. 108" was used for functional testing. The lab catheter met the od specification for the catheter supplied in the reported kit. Comparison of the clamp and catheter measurements indicates that the clamp would securely hold a catheter that has an od of 0. 108". The clamp was disassembled and reassembled with no anomalies observed. The clamp was assembled onto the 8fr lab catheter body and tugged from either side and remained secure in the clamp. Other remarks: a review of the device history records (dhr) for the catheter and clamp did not reveal any manufacturing related issues. The ifu for the product states that the juncture hub is to be used as the primary suture site. The customer did not report whether or not the juncture hub was sutured. The report that the catheter migrated in the clamp could not be confirmed through functional testing of the returned sample. A lab catheter remained secure in the returned catheter clamp when it was tugged. However, the clamp that was returned was a representative sample and not the actual complaint sample. In addition, no catheter was returned. A dhr review was performed and it did not reveal any manufacturing related issues. The probable cause of the catheter migration could not be determined based upon the information provided and without the actual complaint sample.
 
Event Description
The customer alleges that the second site securement device was placed correctly and sutured. After a few minutes, the clamp away from the insertion site did not hold and came apart and the catheter pulled out. No patient injury or consequence reported.
 
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Brand NameARROW MULTI-LUMEN CVC KIT: 2-L 8 FR X 6"
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNACIONAL DE CHIHUAHUA S.A. DE C.V
ave. washington 3701, edificio 4
colonia complejo industrial, las americas
chihuahua 31114
MX 31114
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6431734
MDR Text Key70775689
Report Number3003737899-2017-00021
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Catalogue NumberCDC-42802-P1A
Device Lot Number13F16J0155
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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