MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number	IPN045607
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
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.
Additional Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.The customer reported the catheter separated during use.The customer returned one snaplock assembly and two epidural catheter pieces.The returned snaplock and a catheter piece 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 pieces revealed on the likely most proximal piece, the extrusion is slightly stretched and the coil wire extends approximately 19cm at the likely distal end.The extrusion and coil wire on the likely most distal piece are also stretched at the point of separation at the likely proximal end.Also, both the proximal and distal ends of the returned catheter pieces appear to be intact.The catheter appears to have been used as biological material can be seen on the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the catheter using a ruler (10171599).The proximal end catheter extrusion piece measures approximately 79.5cm.The distal end catheter piece measures approximately 11.6cm.Both catheter pieces combine to measure approxim ately 91.1cm, which is within the specification 88.5-91.5 cm per graphic kz-05400-030 rev.5.None of the catheter appears to be missing.Specifications per graphic kz-05400-030 rev.5 were reviewed as a part of this complaint investigation.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 condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of the epidural catheter separated during use was confirmed based upon the sample received.The customer returned two catheter pieces that were separated at the extrusion.None of the catheter was missing.At the point of separation, the extrusion is slightly stretched on the likely proximal and the likely distal pieces.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, unintentional user error caused or contributed to this event.No further action is required at this time.
Event or Problem Description
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.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Common Device Name: 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 Key: 12647741
• Report Number: 1036844-2021-00168
• Device Sequence Number: 11086705
• Product Code: BSO
• UDI-Device Identifier: 60801902005139
• UDI-Public: 60801902005139
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: IPN045607
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F21D0164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 11/21/2021
• Initial Report FDA Received Date: 10/18/2021
• Supplement Report FDA Received Date: 11/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female