MAUDE Adverse Event Report: PORTEX - SMITHS MEDICAL ASD, INC. EPIDURAL SINGLE SHOT EPIDURAL; ANESTHESIA CONDUCTION KIT

Lot Number 3802013

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2019

Event Type  malfunction  

Event Description

Portex (b)(4) epidural single shot trays had a drape that is listed as fenestrated but there was no hole in the drape.This has involved at least 5 cases in this lot number.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL SINGLE SHOT EPIDURAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): PORTEX - SMITHS MEDICAL ASD, INC. ; minneapolis MN
• MDR Report Key: 8703723
• MDR Text Key: 148295355
• Report Number: MW5087389
• Device Sequence Number: 5
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2019
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3802013
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 120