MAUDE Adverse Event Report: BD CARIBE LTD. BD QUINCKE WHITACRE SPINAL INTRODUCER NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Model Number	405164
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 quincke whitacre spinal introducer needle leaked when paring the syringe and needle.The following information was provided by the initial reporter: verbatim: when pairing syringe with anesthesia in the needle the medicine is spilled.
Event or Problem Description
It was reported that the bd quincke whitacre spinal introducer needle leaked when paring the syringe and needle.The following information was provided by the initial reporter: verbatim: when pairing syringe with anesthesia in the needle the medicine is spilled.
Additional Manufacturer Narrative
Investigation summary no samples or photos received for investigation.A device history review was performed for reported lot 2028709 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures, including leakage, and luer cone fitting verification testing.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.

• Brand Name: BD QUINCKE WHITACRE SPINAL INTRODUCER NEEDLE
• Common Device Name: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17322175
• Report Number: 2618282-2023-00057
• Device Sequence Number: 12143365
• Product Code: BSP
• UDI-Device Identifier: 30382904051649
• UDI-Public: (01)30382904051649
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K210978
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2023

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: Health Professional
• Device Model Number: 405164
• Device Catalogue Number: 405164
• Device Lot Number: 2028709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 08/11/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 08/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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