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

Catalog Number MP-17019-TKL

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

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 the catheter tip is not smooth; it is catching the patient's anatomy and making it very difficult to remove the catheter.There was no reported patient injury.

Manufacturer Narrative

(b)(4).A functional inspection could not be performed as no sample was returned by the customer for investigation.A lot number was not 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 with no relevant findings.The ifu for this kit, (b)(4) was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance the catheter more than 5 cm beyond the needle tip.Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting." 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 a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as a sample not was returned for analysis.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 with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the catheter tip breaking could not be determined based upon the information provided and without a sample.Teleflex will continue to monitor and trend related events.

• Brand Name: EPIDURAL CATHETERIZATION KIT: 19 GA
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 7910473
• MDR Text Key: 121861184
• Report Number: 1036844-2018-00247
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• 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: 09/10/2018

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 Catalogue Number: MP-17019-TKL
• Device Lot Number: 14F18E0287
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 10/25/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1