MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE; ANESTHESIA CONDUCTION KIT

Model Number 405671

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported tray spn whit25g3.5 l/b-d/e plast drape had ineffective anesthesia.The following information was provided by the initial reporter: "today i was notified by anesthesia that the bupivacaine in spinal kit.Does not appear to be effective.".

Manufacturer Narrative

H6: investigation summary one photo was provided showing product label.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001389399 was performed and no recorded quality problems or rejections related to this incident were found.The sterilization records indicated no issues.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.

Event Description

It was reported tray spn whit25g3.5 l/b-d/e plast drape had ineffective anesthesia.The following information was provided by the initial reporter: "today i was notified by anesthesia that the bupivacaine in spinal kit.Does not appear to be effective.".

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12474390
• MDR Text Key: 271472200
• Report Number: 1625685-2021-00062
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: D219092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 0001389399
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1