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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number ASK-05502-BSM
Device Problems Break (1069); Material Separation (1562)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/22/2024
Event Type  Injury  
Event Description
It was reported that: upon removal of the catheter from the patient, part of the tip broke off (distal end of catheter).Additional information: an xray confirmed that the tip of the catheter was in the epidural space, it had to be surgically removed.
 
Manufacturer Narrative
Qn# (b)(4).
 
Manufacturer Narrative
Qn# (b)(4).The customer reported the catheter tip broke off during removal.The customer returned one snaplock assembly, one epidural catheter piece and lidstock.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter piece revealed the proximal end of the catheter was returned and was intact.The returned catheter piece also reveals signs of stretching.The extrusion and coil wire are extremely stretched at the likely most distal end of the catheter and the coil wire extends approximately 6.8cm beyond the extrusion as the distal tip is not intact and was not returned.The returned catheter appears used as biological material can be seen between the inner coils and adhesive material can be seen on the outer extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler.The returned catheter extrusion measures approximately 83.5cm.This indicates at least 5.0cm of the extrusion is missing as the specification for the epidural catheter indicates that the proper extrusion length of an epidural catheter is 88.5-91.5cm per graphic.A device history record review was performed on the epidural catheter with no relevant findings.The ifu for this kit warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu also warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." the reported complaint of epidural catheter tip breaking off during removal was confirmed based upon the sample received.The returned catheter piece showed signs of stretching as the extrusion and coil wire were extremely stretched at the likely most distal end.The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation.Therefore, based upon the condition of the sample received and the observed evidence of the extrusion and coil wire stretching at the distal end, unintentional user error caused or contributed to this event.No further action is required at this time.
 
Event Description
It was reported that: upon removal of the catheter from the patient, part of the tip broke off (distal end of catheter).Additional information: an xray confirmed that the tip of the catheter was in the epidural space, it had to be surgically removed.
 
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Brand Name
ARROW EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.
ave. washington 3701
colonia panamericana, chihuahua
chihuahua 31200
MX   31200
Manufacturer Contact
katharine tarpley
3015 carrington mill blvd
morrisville, NC 27560
MDR Report Key18719765
MDR Text Key335527333
Report Number9680794-2024-00204
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 01/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Catalogue NumberASK-05502-BSM
Device Lot Number33F23K0553
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2024
Is the Reporter a Health Professional? No
Date Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED
Patient Outcome(s) Required Intervention;
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