MAUDE Adverse Event Report: CAREFUSION, INC BD¿ WHITACRE SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 405671

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 07/21/2023

Event Type  Injury  

Event Description

It was reported that the bupivacaine anesthesia in the bd¿ whitacre spinal tray failed to work during the procedure, and the patient required general anesthesia and a longer recovery as a result.The following information was provided by the initial reporter: "customer have been experiencing failed spinals despite proper administration from various providers.This is more than coincidence; it is more of a pattern.I have been told this has happened in the past as well.We suspect that the bupivacaine medication in the kits are being rendered inactive from extreme heat/ sun exposure.Not sure what is the source (transport/storage) but wanted to reach out to you to see if you could help us find a solution to this issue as it directly affects patient care.Additional info received on (b)(6) 2023.Could you please advise the occurrence date for the incident? this record is opened to capture the incident based on the statement ¿ i have been told this has happened in the past as well¿.The incidences occurred several months between april and june 2023.Could you please advise if there is any adverse event on patient due to the incident? an alternate anesthetic plan had to be implemented which required longer recovery for the patient.Was there any medical intervention needed due to the incident? yes, rather than keep patient in natural airway, patient had to be placed under general anesthesia in order to proceed with the surgery.".

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bupivacaine anesthesia in the bd¿ whitacre spinal tray failed to work during the procedure, and the patient required general anesthesia and a longer recovery as a result.The following information was provided by the initial reporter: "customer have been experiencing failed spinals despite proper administration from various providers.This is more than coincidence; it is more of a pattern.I have been told this has happened in the past as well.We suspect that the bupivacaine medication in the kits are being rendered inactive from extreme heat/ sun exposure.Not sure what is the source (transport/storage) but wanted to reach out to you to see if you could help us find a solution to this issue as it directly affects patient care.Additional info received on 09-aug-2023 -could you please advise the occurrence date for the incident? this record is opened to capture the incident based on the statement ¿ i have been told this has happened in the past as well¿.The incidences occurred several months between april and june 2023.-could you please advise if there is any adverse event on patient due to the incident? an alternate anesthetic plan had to be implemented which required longer recovery for the patient.-was there any medical intervention needed due to the incident? yes, rather than keep patient in natural airway, patient had to be placed under general anesthesia in order to proceed with the surgery.".

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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.H3 other text : see h10.

• Brand Name: BD¿ WHITACRE SPINAL TRAY
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17548825
• MDR Text Key: 321154845
• Report Number: 1625685-2023-00078
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: DISCRETION
• 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: 09/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405671
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2023
• 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
• Patient Outcome(s): Required Intervention