MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; AHN CONTINUOUS EPIDURAL

Catalog Number PAIN1422

Device Problem Device Fell (4014)

Patient Problem No Code Available (3191)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the epidural catheter was identified to be falling out of the catheter connector.An unspecified number of patients experienced wet taps, blockage, and the need for a blood patch.After multiple good faith attempts the reporting facility was unable or unwilling to provide additional patient, product, or procedural information to the manufacturer.No sample was returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the epidural catheter was identified to be falling out of the catheter connector.

• Type of Device: AHN CONTINUOUS EPIDURAL
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 9224235
• MDR Text Key: 170110173
• Report Number: 1417592-2019-00182
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: PAIN1422
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention