• 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 CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

  • 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 CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number CS-25802-E
Device Problem Insufficient Information (3190)
Patient Problems Reaction (2414); Bronchospasm (2598)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
"during surgery on (b)(6), the patient had bronchospasm shock once the cvc was inserted.Because the acute allergic reaction happened during surgery, the delayed allergic reactions caused by other medication can be ruled out.Therefore, it was suspected that both fentanyl and chlorhexidine of the cvc coating could be the cause of acute bronchospasm shock.Because the patient continued injecting fentanyl on (b)(6) , it was speculated that the coating chlorhexidine of cvc was more likely to be the cause".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
Customer reports: "during surgery on 4th dec, the patient had bronchospasm shock once the cvc was inserted.Because the acute allergic reaction happened during surgery, the delayed allergic reactions caused by other medication can be ruled out.Therefore, it was suspected that both fentanyl and chlorhexidine of the cvc coating could be the cause of acute bronchospasm shock.Because the patient continued injecting fentanyl on 4th-5th dec, it was speculated that the coating chlorhexidine of cvc was more likely to be the cause".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARROW CVC SET: 2-LUMEN 8 FR X 20 CM
Type of Device
CATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9953549
MDR Text Key187538315
Report Number3006425876-2020-00314
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K900263
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/07/2021
Device Catalogue NumberCS-25802-E
Device Lot Number71F19D1540
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/31/2020
Initial Date FDA Received04/13/2020
Supplement Dates Manufacturer Received05/19/2020
Supplement Dates FDA Received05/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-