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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
Model Number IPN045607
Device Problem Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/08/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Note: based on the additional information a second reported event is coded as serious injury.We had an incident at one of our facilities where the needles broke from two of these kits and one patient had to be taken to surgery to get it removed.We are in the process of getting the lot information and how much inventory is affected in the iu system but we will need to get replacement product sent asap.Additional information: the patient was discharged home in stable condition.She had a surgical removal of the catheter piece by our neurosurgeon.It was completely removed and discarded.There has not been a second patient to my knowledge that had it break while still in the patient.We have a couple that were difficult to remove but were removed fully intact and then broke externally in the crnas hands.
 
Event Description
Note: based on the additional information a second reported event is coded as serious injury.We had an incident at one of our facilities where the needles broke from two of these kits and one patient had to be taken to surgery to get it removed.We are in the process of getting the lot information and how much inventory is affected in the iu system but we will need to get replacement product sent asap.Additional information: the patient was discharged home in stable condition.She had a surgical removal of the catheter piece by our neurosurgeon.It was completely removed and discarded.There has not been a second patient to my knowledge that had it break while still in the patient.We have a couple that were difficult to remove but were removed fully intact and then broke externally in the crnas hands.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.The ifu for this kit, e-17019-109a; rev.07, was reviewed as a part of this complaint investigation.The ifu 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 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 corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the epidural catheter and epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.No further action is required at this time.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key12647689
MDR Text Key276893464
Report Number1036844-2021-00169
Device Sequence Number1
Product Code BSO
UDI-Device Identifier60801902005139
UDI-Public60801902005139
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
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/08/2021
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 Date05/31/2022
Device Model NumberIPN045607
Device Catalogue NumberAK-05502
Device Lot Number23F21C0172
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/08/2021
Initial Date FDA Received10/18/2021
Supplement Dates Manufacturer Received11/21/2021
Supplement Dates FDA Received11/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage A
Patient Sequence Number1
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