MAUDE Adverse Event Report: CAREFUSION, INC 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA CONDUCTION KIT

Catalog Number 400866

Device Problem Labelling, Instructions for Use or Training Problem (1318)

Patient Problem No Patient Involvement (2645)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that blue paper drapes, rather than clear plastic drapes, were found included in the 25gx3.5in whit 5ml glaspak bupi clear before use, despite the product labeled as including clear plastic drapes.The following information was provided by the initial reporter: "customer emailed to say kits came with blue paper drapes but doctors wanted clear plastic drapes.Product is labeled as including clear plastic drape, but blue paper drape was found in tray.".

Event Description

It was reported that blue paper drapes, rather than clear plastic drapes, were found included in the 25gx3.5in whit 5ml glaspak bupi clear before use, despite the product labeled as including clear plastic drapes.The following information was provided by the initial reporter: "customer emailed to say kits came with blue paper drapes but doctors wanted clear plastic drapes.Product is labeled as including clear plastic drape, but blue paper drape was found in tray.".

Manufacturer Narrative

Investigation summary: one photo was received for evaluation.The customer provided photograph confirmed the reported failure mode, the incorrect drape (blue drape) was included in the tray.Based on the complaint investigation, the most probable root cause was that manufacturing personnel did not ensure the correct componentry was used.Based on the identified probable root cause, all applicable manufacturing associates have received awareness training regarding this particular incident and the proper manufacturing process for acquisition of correct componentry prior to assembly.This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences through the quality data analysis process.A lot number was not provided, as a result a dhr review was unable to be performed.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• MDR Report Key: 8784605
• MDR Text Key: 150997127
• Report Number: 1625685-2019-00071
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 400866
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other