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 KIT; ANESTHESIA CONDUCTION CATHETER
  • 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 KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number AK-05502
Device Problem Material Twisted/Bent (2981)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The report states: in placing a labor epidural, there was some difficulty due to patient movement and poor positioning.There was contact with bone, but the needle was redirected to find the epidural space.Nevertheless, there was a good loss of resistance (clear indication that the needle was in the epidural space), and medication was easily dosed through the needle.However, when i tried to pass the epidural catheter through the needle, the catheter movement was blocked and would not pass through the tip of the tuohy needle.After multiple attempts, i aborted the procedure and removed the needle, where i found that the bevel-tip was significantly bent, making it impossible for the plastic catheter to pass through.I had to start over again with a new needle/kit.Eventually, the 2nd kit allowed placement of the epidural catheter, but the delay of treatment caused additional pain for the patient.
 
Event Description
The report states: in placing a labor epidural, there was some difficulty due to patient movement and poor positioning.There was contact with bone, but the needle was redirected to find the epidural space.Nevertheless, there was a good loss of resistance (clear indication that the needle was in the epidural space), and medication was easily dosed through the needle.However, when i tried to pass the epidural catheter through the needle, the catheter movement was blocked and would not pass through the tip of the tuohy needle.After multiple attempts, i aborted the procedure and removed the needle, where i found that the bevel-tip was significantly bent, making it impossible for the plastic catheter to pass through.I had to start over again with a new needle/kit.Eventually, the 2nd kit allowed placement of the epidural catheter, but the delay of treatment caused additional pain for the patient.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the epidural needle with no relevant findings.A design history review was performed for part # kz-05500-007 as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9785938
MDR Text Key181960252
Report Number1036844-2020-00092
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/28/2021
Device Catalogue NumberAK-05502
Device Lot Number23F19F0291
Was Device Available for Evaluation? Yes
Date Manufacturer Received04/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-