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

Catalog Number	405828
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event: unknown.The date received by manufacturer has been used for this field.D4: medical device expiration date: unknown.H4: device manufacture date: unknown.H3: a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd® whitacre spinal needle and bd¿ weiss epidural needle tray was cracked causing leakage.The following was received from 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.Additional info received on 21-july-23: was this noted prior to use? no, it was not noted prior to use.All connectors were used and cracked after initial dosing/administration of test dose.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 14-sep-2023 h.6.Investigation summary: nine 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.The a leak test is performed at incoming, and no issues were identified.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001501051 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.Based on the quality team's investigation, it was identified that the probable root cause is traced to supplier.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.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the bd bd® whitacre spinal needle and bd¿ weiss epidural needle tray was cracked causing leakage.The following was received from 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.Additional info received on 21-july-23 was this noted prior to use? no it was not noted prior to use.All connectors were used and cracked after initial dosing/administration of test dose.

• Brand Name: BD BD® WHITACRE SPINAL NEEDLE AND BD¿ WEISS EPIDURAL NEEDLE TRAY
• Common Device Name: 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: 17674814
• Report Number: 1625685-2023-00085
• Device Sequence Number: 20441697
• Product Code: CAZ
• UDI-Device Identifier: 00382904058289
• UDI-Public: (01)00382904058289
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 09/02/2023
• Supplement Report FDA Received Date: 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown