MAUDE Adverse Event Report: BD CARIBE LTD. BD® QUINCKE SPINAL NEEDLES; ANESTHESIA CONDUCTION NEEDLE

Model Number	405181
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda.Medwatch report # (b)(4).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 during use with bd® quincke spinal needles leakage occurred at the hub.The needle was replaced and patient had to have additional poke, thus resulting in additional pain and discomfort.The following information was provided by the initial reporter: during patient peng (pericapsular nerve group block) peripheral nerve block, 22gx3.5in spinal needle began leaking where the needle joins the clear hub of the needle.It was not a loose connection at the luer lock above where the needle is screwed onto the extension tubing.Anesthesia had to stop nerve block procedure, replace the needle, then poke the patient again.As a result, patient reported discomfort with each poke.
Event or Problem Description
It was reported that during use with bd® quincke spinal needles leakage occurred at the hub.The needle was replaced and patient had to have additional poke, thus resulting in additional pain and discomfort.The following information was provided by the initial reporter: during patient peng (pericapsular nerve group block) peripheral nerve block, 22gx3.5in spinal needle began leaking where the needle joins the clear hub of the needle.It was not a loose connection at the luer lock above where the needle is screwed onto the extension tubing.Anesthesia had to stop nerve block procedure, replace the needle, then poke the patient again.As a result, patient reported discomfort with each poke.
Additional Manufacturer Narrative
H6: investigation summary no samples or photos received by our quality team for evaluation.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.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 SPINAL NEEDLES
• 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 ; 8448235433
• MDR Report Key: 16475485
• Report Number: 2618282-2023-00016
• Device Sequence Number: 11544762
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: (01)30382904051816
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2023

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 Expiration Date: 09/30/2026
• Device Model Number: 405181
• Device Catalogue Number: 405181
• Device Lot Number: 1274747
• 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: 02/03/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 03/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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