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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION CATHETER

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ARROW INTERNATIONAL LLC EPIDURAL CATHETERIZATION KIT: 19 GA; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Model Number IPN925039
Device Problem Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/14/2023
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
It was reported that the nurse attempted to remove the catheter but met resistance.She repositioned the patient and attempted again.Excessive force was not used and when she pulled on the catheter it snapped.The crna ordered a ct scan which confirmed an approximately 1 inch retained portion of the catheter to be located in the epidural space.The fragment of retained catheter was not removed.The patient was discharged home with precautions.
 
Manufacturer Narrative
(b)(4).The reported complaint of epidural catheter breaking during removal was confirmed based upon the sample received.The customer returned one snaplock assembly and one epidural catheter piece.The returned components were received connected to each other.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.The proximal end of the catheter was returned and was revealed to be intact upon visual inspection.The returned catheter piece also revealed signs of stretching.The extrusion and coil wire are extremely stretched at the likely most distal end of the catheter as the distal tip is not intact and was not returned.The catheter appears to have been used, as evidenced by the presence of biological material between the inner coils and adhesive material on the outer extrusion.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter piece via a calibrated ruler and the catheter extrusion measured approximately 85.6cm.This indicates at least 2.9cm 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.Additionally, 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." a device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, there was no record of purchase of this product by this customer.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.Other remarks: n/a.Corrected data: n/a.
 
Event Description
It was reported that the nurse attempted to remove the catheter but met resistance.She repositioned the patient and attempted again.Excessive force was not used and when she pulled on the catheter it snapped.The crna ordered a ct scan which confirmed an approximately 1 inch retained portion of the catheter to be located in the epidural space.The fragment of retained catheter was not removed.The patient was discharged home with precautions.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT: 19 GA
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL LLC
morrisville NC
Manufacturer (Section G)
ARROW INTERNATIONAL LLC
3015 carrington mill blvd
morrisville NC 27560
Manufacturer Contact
kevin don bosco
3015 carrington mill blvd
morrisville 27560
MDR Report Key16923591
MDR Text Key315173427
Report Number3013162291-2023-00001
Device Sequence Number1
Product Code BSO
UDI-Device Identifier10801902210224
UDI-Public10801902210224
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 Health Professional,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 04/21/2023
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 Model NumberIPN925039
Device Catalogue NumberMP-17019-TKL
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/11/2023
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/21/2023
Initial Date FDA Received05/12/2023
Supplement Dates Manufacturer Received06/06/2023
Supplement Dates FDA Received06/15/2023
Was Device Evaluated by Manufacturer? Yes
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
N/A.; N/A.
Patient SexFemale
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