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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number AK-05502
Device Problem Material Twisted/Bent (2981)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 02/19/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that in placing a labor epidural, there was some difficulty due to patient movement and poor positioning.There was contact with bone, but the needle was redirected to find the epidural space.Nevertheless, there was a good loss of resistance (clear indication that the needle was in the epidural space), and medication was easily dosed through the needle.However, when i tried to pass the epidural catheter through the needle, the catheter movement was blocked and would not pass through the tip of the needle.After multiple attempts, i aborted the procedure and removed the needle, where i found that the bevel-tip was significantly bent, making it impossible for the plastic catheter to pass through.I had to start over again with a new needle/kit.Eventually, the 2nd kit allowed placement of the epidural catheter, but the delay of treatment caused additional pain for the patient.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural needle with no relevant findings.The customer reported the epidural needle's tip was bent.The customer returned one sealed representative kit from the same lot # as reported on the complaint (23f19f0291) for investigation (reference files (b)(4)).The actual complaint sample was not received.The returned kit was opened, and the epidural needle was removed and was visually examined.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.A dimensional inspection was performed on the returned epidural needle.The id measured 0.046in (1.17mm) (ref-(b)(4)), which is within specification of 1.17mm per graphic kz-05500-007; rev 9.Since the needle returned was from a sealed representative sample, 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 (ref-(b)(4)).The catheter could thread through the returned needle with no resistance met.The components passed the drag test.Specifications per graphic kz-05500-007, rev 9 was reviewed as a part of this complaint investigation.A design history review was performed for part # kz-05500-007 as a part of this complaint investigation.There have been no material changes for this part during the last two years that could have led to this complaint.A corrective action is not required at this time as the complaint could not be confirmed based upon the information provided and without the actual complaint sample.The representative sample received was functionally tested and visually inspected with no issue found.The reported complaint of a bent needle could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.Since a representative sample was returned, functional testing was performed on the returned catheter and needle.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 was found to be within specification.A device history record review was performed on the needle with no relevant findings.A potential root cause could not be determined based upon the information provided or without the actual complaint sample.
 
Event Description
It was reported that in placing a labor epidural, there was some difficulty due to patient movement and poor positioning.There was contact with bone, but the needle was redirected to find the epidural space.Nevertheless, there was a good loss of resistance (clear indication that the needle was in the epidural space), and medication was easily dosed through the needle.However, when i tried to pass the epidural catheter through the needle, the catheter movement was blocked and would not pass through the tip of the needle.After multiple attempts, i aborted the procedure and removed the needle, where i found that the bevel-tip was significantly bent, making it impossible for the plastic catheter to pass through.I had to start over again with a new needle/kit.Eventually, the 2nd kit allowed placement of the epidural catheter, but the delay of treatment caused additional pain for the patient.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9844946
MDR Text Key183881821
Report Number1036844-2020-00085
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 02/20/2020
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 Date02/28/2021
Device Catalogue NumberAK-05502
Device Lot Number23F19F0291
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2020
Initial Date Manufacturer Received 02/20/2020
Initial Date FDA Received03/17/2020
Supplement Dates Manufacturer Received04/07/2020
Supplement Dates FDA Received04/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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