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; 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
Catalog Number EJ-05400-E
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.
 
Event Description
The catheter came off the snaplock adapter.It is unknown whether the snaplock adapter securement clip was used or not.The catheter was removed and a new one inserted 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 and snaplock adapter with no relevant findings.The customer reported that the snaplock adapter disconnected from the catheter.The customer returned one snaplock adapter with clip, one flat filter, and one epidural catheter ((b)(4)).The returned components were visually examined with and without magnification.The snaplock adapter appears typical with no defects or anomalies observed.The flat filter appears typical with no defects or anomalies observed.Visual examination of the returned epidural catheter revealed that the catheter appears used.Biological material can be seen between the catheter coils and adhesive residue is present on the catheter body exterior.No other defects or anomalies were observed.A functional leak test was performed on the returned sample per mrq 000017 section 6.5; rev.5.The returned epidural catheter was inserted from the proximal end into the returned snaplock adapter until it bottomed out and the snaplock adapter was other remarks: closed.The components were confirmed to be secured by tugging gently.The snaplock adapter was connected to the lab leak tester (c05176) and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was capped off and the pressure was increased to 25 psi for 30 seconds.No leaks were detected and the components remained secured.A functional spo test was then performed per mrq 000017 section 6.7; rev 5.The proximal end of the epidural catheter was re-inserted into the snaplock adapter until it bottomed out and the snaplock adapter was locked.The components were confirmed to be secured by tugging gently on the catheter.The components were then left to sit for 72 hours in the locked position.After 72 hours, the snaplock adapter was confirmed to have remained securely locked with the catheter inserted.No functional issues were found (reference files (b)(4)).No corrective action needed at this time since no functional issues were found with the returned snaplock adapter.The reported complaint of the snaplock adapter disconnecting from the catheter could not be confirmed through functional testing of the returned snaplock adapter.The snaplock adapter was secured to the epidural catheter and passed the functional tests performed including a spontaneous partial opening (spo) test.There was no problem found with the returned snaplock adapter.
 
Event Description
The catheter came off the snaplock adapter.It is unknown whether the snaplock adapter securement clip was used or not.The catheter was removed and a new one inserted in the patient.The patient's condition was reported as fine.
 
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
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6179449
MDR Text Key62534760
Report Number3006425876-2016-00385
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/30/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberEJ-05400-E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/16/2017
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 N
Patient Sequence Number1
-
-