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

Model Number 405181

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 02/03/2023

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 310863731
• Report Number: 2618282-2023-00016
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 30382904051816
• UDI-Public: (01)30382904051816
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• 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
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 03/07/2023
• Supplement Dates FDA Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2021
• 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