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

Model Number IPN923949

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.

Event Description

Outside of catheter was uncoiled from inner portion similar to unwound string.Due to epidural catheter, patient required general anesthesia.Stable post-delivery.Patient epidural tubing had a mechanical tubing malfunction.Tubing catheter was assessed q 1 hours.While transitioning patient from room to or connection tubing was broken.Staff, charge, anesthesiologist, and safety officer aware that connection tubing broke.Epidural catheter removed in the or after stat c-section.Two nurses, surgical tech, and anesthesiologist present for removal.Catheter tubing intact with no complications upon removal.

Event Description

Outside of catheter was uncoiled from inner portion similar to unwound string.Due to epidural catheter, patient required general anesthesia.Stable post-delivery.Patient epidural tubing had a mechanical tubing malfunction.Tubing catheter was assessed q 1 hours.While transitioning patient from room to or connection tubing was broken.Staff, charge, anesthesiologist, and safety officer aware that connection tubing broke.Epidural catheter removed in the or after stat c-section.Two nurses, surgical tech, and anesthesiologist present for removal.Catheter tubing intact with no complications upon removal.

Manufacturer Narrative

(b)(4).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.The customer reported the catheter separated during use.The customer returned one epidural catheter.The returned sample was visually examined with and without magnification.Visual examination of the returned catheter revealed the extrusion and coil wire at the proximal end appears to be slightly stretched.The coil wire extends approximately 34.3cm beyond the extrusion as the proximal end appears to be missing.The distal side of the catheter appears to be intact as no damage was observed.The catheter appears to have been used as 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 using a ruler.The returned catheter extrusion measures approximately 80.8cm.This indicates at least 7.7cm 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 kz-05400-030, rev.5.Specifications per graphic , were reviewed as a part of this complaint investigation.The ifu for this kit was reviewed as a part of this complaint investigation.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." in summary, the reported complaint of the catheter separating during use was confirmed based upon the sample received.The returned catheter showed signs of stretching at the proximal end as the proximal end was missing.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 proximal end, unintentional user error caused or contributed to this event.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• 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: 15328928
• MDR Text Key: 304873653
• Report Number: 1036844-2022-00068
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 10801902207453
• UDI-Public: 10801902207453
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN923949
• Device Catalogue Number: AK-05503
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female