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 07/14/2023

Event Type  malfunction  

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.

Event Description

It was reported that an unspecified number of bd¿ whitacre spinal trays had issues with ineffective marcaine during medical surgeries and procedures.The following information was provided by the initial reporter: "customer is concerned that sku # 405671 under lot # 0001513983 doesn¿t work.(b)(6) 2023, i have an additional update from the customer: ¿my anesthesiologist/crna are complaining that the marcaine is not numbing the area of the body to relieve pain during surgery or medical procedures and childbirth.The patient¿s blood pressure has elevated in the middle of surgical procedures due to the marcaine not working.Since we have tried several trays with that same lot# and the same results has happen.I have been instructed to pull all spinal from my inventory in surgery and labor/delivery.¿".

Event Description

It was reported that an unspecified number of bd¿ whitacre spinal trays had issues with ineffective marcaine during medical surgeries and procedures.The following information was provided by the initial reporter: "customer is concerned that sku # 405671 under lot # 0001513983 doesn¿t work.17july2023 i have an additional update from the customer: ¿my anesthesiologist/crna are complaining that the marcaine is not numbing the area of the body to relieve pain during surgery or medical procedures and childbirth.The patient¿s blood pressure has elevated in the middle of surgical procedures due to the marcaine not working.Since we have tried several trays with that same lot# and the same results has happen.I have been instructed to pull all spinal from my inventory in surgery and labor/delivery.¿".

Manufacturer Narrative

H6: 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 number 0001513983 was 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.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.Supplier was also notified of the reported failure mode.

• 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: 17503080
• MDR Text Key: 321366758
• Report Number: 1625685-2023-00074
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 405671
• Device Lot Number: 0001513983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2023
• 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