MAUDE Adverse Event Report: EPIDURAL; MINI PACK

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Information received a smiths medical epidural custom pack malfunctioned.Immediately after starting to use the product, the customer noticed fluid leaked from the filter.No patient injury.

Manufacturer Narrative

Other, other text: h10 ? device evaluation results: when water was injected into the returned product with a syringe, a liquid leak occurred from the central part of one side of the flat filter.The following causes are possible for this event, but the timing and cause of the occurrence were not identified.A definitive root cause was not established.-cracks occur during the manufacturing process at the filter manufacturer -a crack was created by some external impact.

• Brand Name: EPIDURAL
• Type of Device: MINI PACK
• MDR Report Key: 10558107
• MDR Text Key: 207690739
• Report Number: 3012307300-2020-09574
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1