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

Catalog Number AK-05000

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that a caudal epidural procedure was successful but there was an issue when pulling out the catheter.The user had to pull needle with catheter.It was thought that the catheter may have gotten caught on tip of needle.The catheter ended up shredded.There was no reported patient injury.

Manufacturer Narrative

(b)(4).No lot number was provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter and needle with no relevant findings.The ifu for this kit, e-17019-109a; rev.6, 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.The ifu also provides alternate removal techniques if further resistance is encountered.The ifu states "stretch catheter slightly and tape it to skin, creating constant tension on the catheter." also, "injecting a small bolus of preservative-free saline while removing the catheter may be helpful." a corrective action is not required at this time.Based on the provided photos indicates operational context caused or contributed to this event.Complaint verification testing could not be performed as no sample was returned for analysis.However, the reported complaint of the catheter becoming damaged during removal was confirmed based on photos provided from the customer.Visual examination of the customer provided photos clearly reveal a damaged catheter.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter and needle with no evidence to suggest a manufacturing related cause.Therefore, based on the photos provided, operational context caused or contributed to this event.

Event Description

It was reported that a caudal epidural procedure was successful but there was an issue when pulling out the catheter.The user had to pull needle with catheter.It was thought that the catheter may have gotten caught on tip of needle.The catheter ended up shredded.There was no reported patient injury.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCT KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7713649
• MDR Text Key: 114821564
• Report Number: 1036844-2018-00221
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K801912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AK-05000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1