MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL; ANESTHESIA CONDUCTION NEEDLE

Catalog Number	405164
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that medication leaked from the bd¿ spinal needle with quincke bevel and syringe connection site during use.The following information was provided by the initial reporter, translated from spanish: "when the syringe is connected to the needle, the medication leaks and much of it is lost, the syringe is not well attached to the needle, which causes much of the medication to be lost.".
Additional Manufacturer Narrative
H.3.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 medication leaked from the bd¿ spinal needle with quincke bevel and syringe connection site during use.The following information was provided by the initial reporter, translated from spanish: "when the syringe is connected to the needle, the medication leaks and much of it is lost, the syringe is not well attached to the needle, which causes much of the medication to be lost.".
Additional Manufacturer Narrative
Investigation summary: one video received by our quality team for investigation.Through visual evaluation, it is observed the process of a puncture is being performed, during this process the syringe leaks through the upper part of the hub.A device history review was performed for lot 2108321, 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.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: BD¿ SPINAL NEEDLE WITH QUINCKE BEVEL
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17541744
• Report Number: 2618282-2023-00065
• Device Sequence Number: 7570384
• Product Code: BSP
• UDI-Device Identifier: 00382904051648
• UDI-Public: 00382904051648
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 405164
• Device Lot Number: 2108321
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 09/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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