Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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. EPIDURAL CATHETERIZATION SET
  • 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. EPIDURAL CATHETERIZATION SET Back to Search Results
Catalog Number JC-05400-B
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problems Cerebrospinal Fluid Leakage (1772); No Information (3190)
Event Date 05/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The facility has communicated that the device is not available for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The report indicates that the user suggests that the product has been changed.Since this change they have noticed a spinal tap.The former catheter was smoother.It is noted that in 6 weeks they have had a spinal tap 12 times; lumbar puncture after confirmation that the needle was placed correctly in the epidural space.
 
Event Description
The report indicates that the user suggests that the product has been changed.Since this change they have noticed a spinal tap.The former catheter was smoother.It is noted that in 6 weeks they have had a spinal tap 12 times; lumbar puncture after confirmation that the needle was placed correctly in the epidural space.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed with a potentially relevant finding.A nonconformance was initiated only as a general nc to temporarily allow certain finished good part numbers to be packaged with additional gauze in order to better secure medication ampules in the inner tray.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed with a potentially relevant finding.Based on the information provided, the potential root cause of this issue is design related.A capa was initiated to further investigate this complaint issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIDURAL CATHETERIZATION SET
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8682249
MDR Text Key147458414
Report Number3006425876-2019-00411
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/16/2021
Device Catalogue NumberJC-05400-B
Device Lot Number71F19B2664
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-