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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET
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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.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter doesn't insert smoothly.The customer returned one opened kit (reference attached files (b)(4)).The epidural needle and catheter were removed.The components were visually examined with and without magnification.Visual examination of the returned needle revealed that the needle appears typical.The needle bevel appears polished and smooth with no observed burrs.The needle cannula appears typical.No defects or anomalies were observed.Visual examination of the returned catheter revealed that the catheter appears typical with no defects or anomalies observed.A dimensional inspection was performed on the returned epidural needle.Inner diameter (id) measurement of the returned needle revealed a value of 0.046" (1.1938mm) using pin gauges (c05157), which is within the specification range of 1.19mm-1.22mm per graphic (b)(4).A dimensional inspection was performed on the returned epidural.The outer diameter (od) of the returned catheter measured 1.04mm (caliper c05155) which is within the specification of a maximum of 1.115mm per graphic (b)(4); rev 9.A functional test was performed by attempting to thread the returned catheter through the returned epidural needle.The catheter was thread at the distal end and would thread through the epidural needle with no resistance met.A drag test was performed per pip-013, rev 3 using the returned components and a weight (c05406).The catheter could thread through the returned needle with no resistance met.The components passed the drag test.Specifications per graphic (b)(4) were reviewed as a part of this complaint investigation.A design history review was performed for part # kz-05400-002 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as no functional or dimensional issues could be found with the returned sample as the returned catheter looked typical and threaded through the returned needle with no issues.The reported complaint of the catheter not being smooth during insertion could not be confirmed based on the sample received.The returned catheter could be thread through the returned needle with no resistance met.The returned components passed a functional drag test, and the returned needle id and returned catheter od were found to be within specification.A device history record review was performed on the catheter with no relevant findings.Therefore, there were no issues found with the returned sample.
 
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.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8683139
MDR Text Key147856867
Report Number3006425876-2019-00401
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? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2019
Date Manufacturer Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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