MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY 27G X 3.5" WHITACRE SPINAL NEEDLE; ANESTHESIA CONDUCTION KIT

Model Number 405699

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd spinal anesthesia tray 27g x 3.5" whitacre spinal needle expired product was received.There was no report of patient impact.The following information was provided by the initial reporter: material# 405699, batch# unknown.It was reported by the customer that there is an expiration date issue with the contents of the tray.Verbatim: we have had nurses on the ob floor open trays that on the outside indicate that they are still within the usable date.But upon opening them, the marcaine that comes in the trays are expired.This makes it difficult for us to know wither the trays are good to use and what we will need to get rid of.

Event Description

It was reported while using bd spinal anesthesia tray 27g x 3.5" whitacre spinal needle expired product was received.There was no report of patient impact.The following information was provided by the initial reporter: material# 405699; batch# unknown.It was reported by the customer that there is an expiration date issue with the contents of the tray.Verbatim: we have had nurses on the ob floor open trays that on the outside indicate that they are still within the usable date.But upon opening them, the marcaine that comes in the trays are expired.This makes it difficult for us to know wither the trays are good to use and what we will need to get rid of.

Manufacturer Narrative

H6: investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review could not be completed as no batch number was provided.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: BD SPINAL ANESTHESIA TRAY 27G X 3.5" WHITACRE SPINAL NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15353669
• MDR Text Key: 305056893
• Report Number: 1625685-2022-00084
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 405699
• Device Catalogue Number: 405699
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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