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

Catalog Number	405164
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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¿ spinal needle with quincke bevel leaked medicine from the syringe connection during use.The following information was provided by the initial reporter, translated from spanish: "the anesthesiologists say that the syringe does not fit the needle and leaks when the medicine leaves.".
Event or Problem Description
It was reported that the bd¿ spinal needle with quincke bevel leaked medicine from the syringe connection during use.The following information was provided by the initial reporter, translated from spanish: "the anesthesiologists say that the syringe does not fit the needle and leaks when the medicine leaves.".
Additional Manufacturer Narrative
The following was updated with additional information: imdrf annex a grid - medical device problem code - a1205.H6: investigation summary: no photos or physical samples that display the reported condition were provided for investigation.A device history review was performed for the reported lot 1120619 and 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 available information, we cannot identify a root cause 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
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15859394
• Report Number: 2618282-2022-00079
• Device Sequence Number: 17572187
• Product Code: BSP
• UDI-Device Identifier: 00382904051648
• UDI-Public: (01)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): 11/29/2022

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 Expiration Date: 04/30/2026
• Device Catalogue Number: 405164
• Device Lot Number: 1120619
• 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: 11/01/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2021
• 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