MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL TRAY 25 GAUGE 3.5 INCH; ANESTHESIA CONDUCTION KIT

Model Number 405671

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported while using bd spinal tray 25 gauge 3.5 inch the anesthesia was ineffective.There was no report of patient impact.The following information was provided by the initial reporter: reported an issue with the bupivacaine drug in anesthesia spinal tray sub manufacturer item # 405671 lot # 0001485821.Date of event : reported on (b)(6) 2022.Was there a sample of the product available for evaluation ? we have 1 of the defection trays ready to ship.Was there any patient harm reported? no.

Manufacturer Narrative

Address information was not able to be obtained, therefore, (b)(6) was used as a place holder.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 tray 25 gauge 3.5 inch the anesthesia was ineffective.There was no report of patient impact.The following information was provided by the initial reporter: reported an issue with the bupivacaine drug in anesthesia spinal tray sub manufacturer item # 405671 lot # 0001485821.Date of event : reported on 10/24/2022 was there a sample of the product available for evaluation ? we have 1 of the defection trays ready to ship.Was there any patient harm reported? no.

Manufacturer Narrative

The following feilds were corrected: c.1.Suspect drug: bupivacaine hcl (0.75%) with dextrose (8.25%), 2 ml (marcaine).G.5.Is combination product?: yes.Device evaluation: h6: investigation summary one sample of lot 0001485821 was provided to our quality team for investigation.Through visual inspection of marcaine, no visually identifiable issues with the product found; 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 0001485821 was performed and no recorded quality problems or rejections related to this incident were found.Based on the available information we are not able to identify a root cause at this time.H3 other text : see h10.

• Brand Name: BD SPINAL TRAY 25 GAUGE 3.5 INCH
• 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: 15800934
• MDR Text Key: 307564425
• Report Number: 1625685-2022-00097
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: (01)00382904056711
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: 0001485821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2022
• 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