• 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; 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 SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN046311
Device Problem Premature Separation (4045)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the catheter was inserted was success.But when they removed the trocar(which is the improper term used - can be the needle tbc) the catheter separated in 2 at 2/3rd of the upper point.Clinical consequences: no consequence because the catheter was still long enough to be used.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.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 on the epidural catheter and needle with no relevant findings.The potential cause of this complaint could not be determined based upon the information provided and without a sample.
 
Event Description
It was reported that the catheter was inserted was success.But when they removed the trocar(which is the improper term used - can be the needle tbc)the catheter separated in 2 at 2/3rd of the upper point.Clinical consequences: no consequence because the catheter was still long enough to be used.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9552751
MDR Text Key179718429
Report Number3006425876-2020-00048
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/22/2021
Device Model NumberIPN046311
Device Catalogue NumberJC-05400-B
Device Lot Number71F19G2970
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/12/2019
Initial Date FDA Received01/06/2020
Supplement Dates Manufacturer Received01/28/2020
Supplement Dates FDA Received02/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-