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 07/19/2023

Event Type  malfunction  

Event Description

It was reported that while using the bupivacaine medication in the bd¿ whitacre spinal tray it is being rendered inactive.The following was received 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.Please let me know if there is anything we can do to help assist with a solution! thank you, peoplesoft number (b)(4), becton dickinson item (b)(4), owens and minor number (b)(4).A affected lots 0001514100 and 0001510709 of the kits that they had issues with.

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6.Investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers 0001514100, 0001510709 were performed and no recorded quality problems or rejections related to this incident were found.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.The sterilization records were reviewed, and a deviation occurred.Retain samples were analyzed, per the drug retain visual examination procedure, and no issues were identified.Based on the available information we are not able to identify a root cause at this time.A quality notification was sent to the supplier.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that while using the bupivacaine medication in the bd¿ whitacre spinal tray it is being rendered inactive.The following was received 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.Please let me know if there is anything we can do to help assist with a solution! thank you, people soft number (b)(4), becton dickinson item 405671, owens and minor number (b)(4).A affected lots 0001514100 and 0001510709 of the kits that they had issues with.

• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17476692
• MDR Text Key: 321527193
• Report Number: 1625685-2023-00075
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• Combination Product (y/n): N
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405671
• Device Lot Number: 0001510709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2023
• 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