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

Catalog Number JH-05500

Device Problem Difficult to Advance (2920)

Patient Problem No Information (3190)

Event Date 07/14/2020

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 does not feed well once placed.Additional information: the anesthetist was unable to complete insertion; catheter would not advance requiring a second attempt.

Event Description

It was reported that the catheter does not feed well once placed.Additional information: the anesthetist was unable to complete insertion; catheter would not advance requiring a second attempt.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.A review of design change history for kit jh-05500, part number an-02017-002, and kz-05400-030 was performed as a part of this inves tigation.No design changes have been made to this product in the past two years that would have led to this complaint.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 no sample was returned for analysis.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of catheter not advancing could not be determined based upon the information provided and without a sample.

• Brand Name: EPIDURAL CATHETERIZATION SETS
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10384500
• MDR Text Key: 202195249
• Report Number: 1036844-2020-00230
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2020

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 Date: 02/28/2021
• Device Catalogue Number: JH-05500
• Device Lot Number: 13F19H0332
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/28/2020
• Supplement Dates FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1