MAUDE Adverse Event Report: CAREFUSION, INC BD SPINAL ANESTHESIA TRAY - BD WHITACRE SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 01/17/2023

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 anesthesia tray - bd whitacre spinal needle the anesthesia did not work properly.There was no report of patient impact.The following information was provided by the initial reporter: customer reports they had 1 trays pn 400866, lot 1439606 here the drug was not working.They reported good spinal return but lack of efficacy.No injury reported.

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 0001439606 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.Retains were reviewed and no issues from the site were found.Based on the available information we are not able to identify a root cause at this time.

Event Description

It was reported while using bd spinal anesthesia tray - bd whitacre spinal needle the anesthesia did not work properly.There was no report of patient impact.The following information was provided by the initial reporter: customer reports they had 1 trays pn 400866 lot 1439606 here the drug was not working.They reported good spinal return but lack of efficacy.No injury reported.

• Brand Name: BD SPINAL ANESTHESIA TRAY - BD WHITACRE SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• 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: 16318631
• MDR Text Key: 309065312
• Report Number: 1625685-2023-00015
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 50382904008661
• UDI-Public: (01)50382904008661
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400866
• Device Lot Number: 0001439606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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