MAUDE Adverse Event Report: CAREFUSION, INC BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number 405828

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 07/14/2023

Event Type  malfunction  

Manufacturer Narrative

D.4 device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that the bd bd® whitacre spinal needle and bd¿ weiss epidural needle tray was cracked causing leakage.The following information was provided by the initial reporter: we are having major issues with the connectors for the catheter in our current cse kit.They crack and epidural solution is delivered to the bed instead of the epidural space.Please advise on next steps to correct the issue as this is a patient safety concern.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-oct-2023 h6: investigation summary eight samples were received by our quality team for investigation.Upon visual inspection, it was observed that the cracks were present at the luer end of the connector therefore, the reported failure mode was confirmed.A device history review could not be completed as no batch number was provided.Based on the available information, the root cause of the issue corresponds to a supplier defect, a quality notification to the supplier to raise awareness and give them the opportunity to investigate.Awareness training will be performed with the incoming inspection team to raise awareness.H3 other text : see h10.

Event Description

It was reported that the bd bd® whitacre spinal needle and bd¿ weiss epidural needle tray was cracked causing leakage.The following information was provided by the initial reporter: we are having major issues with the connectors for the catheter in our current cse kit.They crack and epidural solution is delivered to the bed instead of the epidural space.Please advise on next steps to correct the issue as this is a patient safety concern.

• Brand Name: BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE 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: 17456196
• MDR Text Key: 321327590
• Report Number: 1625685-2023-00073
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: (01)00382904058289
• 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,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: 08/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 405828
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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