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

Model Number 405164

Device Problem Leak/Splash (1354)

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

Event Date 06/22/2023

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 319142193
• Report Number: 2618282-2023-00057
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051649
• UDI-Public: (01)30382904051649
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K210978
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2022
• 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