• 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: 19 GA ANESTHESIA CONDUCTION KIT

  • 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: 19 GA ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number AK-05501
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation. Teleflex will continue ot monitor and trend related events.
 
Event Description
It was reported that the catheter tip broke off into the patient during an epidural procedure. The tip remains in the patient. The patient's condition was reported as fine.
 
Manufacturer Narrative
Qn# (b)(4). No lot number was provided. A device history record review was performed based upon a lot number from sales history data. A device history record review was performed on the epidural catheter with no relevant findings. The ifu for this kit, e-17019-109a; rev. 06, was reviewed as a part of this complaint investigation. The ifu warns the end user, "never advance the catheter more than 5 cm beyond the needle tip. Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting. " the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage. Do not apply additional tension on the catheter if catheter begins to stretch excessively. Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal. A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample. Complaint verification testing could not be performed as no sample was returned for analysis. A device history record review was performed based upon a lot number from sales history data. A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related cause. Therefore, the potential cause of the catheter tip breaking could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that the catheter tip broke off into the patient during an epidural procedure. The tip remains in the patient. The patient's condition was reported as fine.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEPIDURAL CATHETERIZATION KIT: 19 GA
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key7647570
MDR Text Key112747727
Report Number1036844-2018-00185
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAK-05501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-