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

Model Number 405671

Device Problem Obstruction of Flow (2423)

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

Event Date 05/11/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event.The date received by manufacturer has been used for this field.Suspect products name and strength: bupivacaine (0.75%) with dextrose (8.25%) 2 ml (marcaine).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 while using bd spinal anesthesia tray during spinal injections, a few of the products have had a delayed release of marcaine.The following information was provided by the initial reporter: during spinal injections, a few of the products have had a delayed release of marcaine.Resulting in higher doses delivered to the patient than desired.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 18-jul-2022.One sample was provided to our quality team for investigation.Upon visual inspection of the retention sample ampules and fluids it was observed that retention samples were clear and colorless therefore, the reported failure mode was not confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001460001 was performed and no recorded quality problems or rejections related to this incident were found.

Event Description

It was reported while using bd spinal anesthesia tray during spinal injections, a few of the products have had a delayed release of marcaine.The following information was provided by the initial reporter: during spinal injections, a few of the products have had a delayed release of marcaine.Resulting in higher doses delivered to the patient than desired.

• Brand Name: BD SPINAL ANESTHESIA 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14685022
• MDR Text Key: 301814205
• Report Number: 1625685-2022-00064
• 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: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 0001460001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2022
• 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