• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT: 9 FR DISTAL X 4-1/2 CATHETER, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. ARROW MULTI-LUMEN/PSI KIT: 9 FR DISTAL X 4-1/2 CATHETER, INTRAVASCULAR Back to Search Results
Catalog Number ASK-21242-NYP
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); Reaction (2414)
Event Date 01/04/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The results of the investigation are incomplete at the time of this report.
 
Event Description
The customer alleges that the patient was induced under general anesthesia and successfully trached. Drugs given were: midazolam, fentanyl, propofol, and rocuronium. The patient was then stable. Approx 15-20 min later the patient was prepped for introducer insertion (9fr. Mac placed). Insertion went smoothly. Hr went from 60-90, b/p fell - map into 40's. Head was red and flush. Physician paused then removed catheter. Prior to removal, vaso pressor given with no effect. Through piv several doses of epinephrine were administered. Patient stabilized in 10-15 mins. Procedure cancelled. Allergist saw patient and will be testing for chlorhexidine and sulfur allergy. The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn#(b)(4). The sample was not returned for evaluation. The lot number was not reported; therefore, the device history record (dhr) review was performed based on sales history of the customer. There were no relevant findings. The ifu for this product states this catheter is contraindicated for patients with a known hypersensitivity to chlorhexidine, silver sulfadiazine and/or sulfa drugs. It also warns that hypersensitivity reactions are a concern with antimicrobial catheters in that they can be very serious and even life-threatening. Complaint verification testing could not be performed as no sample was returned for analysis. A dhr review did not reveal any manufacturing related issues. The probable cause of the patient experiencing an allergic reaction after the sheath insertion could not be determined based on the information provided and without a sample. If the sample is returned, a follow-up report will be submitted with investigation results.
 
Event Description
The customer alleges that the patient was induced under general anesthesia and successfully trached. Drugs given were: midazolam, fentanyl, propofol, and recuronium. The patient was then stable. At 15-20 min later, the patient was prepped for introducer insertion (9fr. Mac placed). Insertion went smoothly. Hr went from 60-90, b/p fell - map into 40's. Head was red and flush. Physician paused then removed catheter. Prior to removal, vaso pressor given with no effect. Through piv several doses of epinephrine were administered. Patient stabilized in 10-15 mins. Procedure cancelled. Allergist saw patient and will be testing for chlorhexidine and sulfur allergy. The patient's condition is reported as fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARROW MULTI-LUMEN/PSI KIT: 9 FR DISTAL X 4-1/2
Type of DeviceCATHETER, INTRAVASCULAR
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
9194334854
MDR Report Key6253594
MDR Text Key64929764
Report Number1036844-2017-00027
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2018
Device Catalogue NumberASK-21242-NYP
Device Lot Number23F16G0286
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-