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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT Back to Search Results
Catalog Number ASK-05500-KM
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2018
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
It was reported that there was resistance during catheter insertion; it was pulled out and the tip was slightly deformed. A new catheter was inserted.
 
Event Description
It was reported that there was resistance during catheter insertion; it was pulled out and the tip was slightly deformed. A new catheter was inserted.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural needle and epidural catheter with no relevant findings. The customer reported the catheter resistance was felt when inserting the catheter and the catheter's tip is slightly deformed. The customer returned one opened kit (reference files (b)(4)). The epidural needle and epidural catheter were removed from the received kit. 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's distal tip appears to be slightly bent as compared to a lab inventory catheter (reference files (b)(4)). No other anomalies or defects were observed. The customer also returned a photo (reference files (b)(4)). A dimensional inspection was performed on the returned epidural needle. Inner diameter (id) measurement of the returned needle revealed a value of 0. 047" using pin gauges (c05157), which is within specification (0. 46" minimum) per graphic j-05560-003, rev 9. A dimensional inspection was performed on the returned epidural. The outer diameter (od) of the returned catheter measured 1. 05mm (caliper c05155) which is within the specification of a maximum of 1. 115mm per graphic kz-05400-002; 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 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 j-05560-003, rev 9 and kz-005400-002; rev 9 were reviewed as a part of this complaint investigation. A design history review was performed for part # j-005560-003 and kz-005400-002 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. The reported complaint of resistance being felt during insertion of the catheter needle could not be confirmed based on the sample received. A device history record review was performed on the epidural needle and catheter with no evidence to suggest a manufacturing related issue. Although the returned catheter's distal tip appeared to be slightly bent as compared to a lab inventory catheter, it had no impact on the functionality of the catheter. The returned catheter could be thread into the returned epidural needle with no resistance met as well as pass a functional drag test. Based on the test results, there were no functional issues were found with the returned sample.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7710026
MDR Text Key114939584
Report Number3006425876-2018-00430
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 06/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/08/2019
Device Catalogue NumberASK-05500-KM
Device Lot Number71F17H1724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/01/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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