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

Catalog Number 405180

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Headache (1880)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 30 bd¿ quincke spinal needles caused spinal headaches to occur following use.There was no long-term adverse impact reported.The following information was provided by the initial reporter: "5g quinckie spinal needles cause a higher incidence of spinal headache following use and our anesthesiologists have stated that this needle is not appropriate for use in this setting, and they will not use them on our pregnant population.Patient injury? (y/n) no long-term adverse impact, but spinal needles cause a higher incidence of spinal headache.

• Brand Name: BD¿ QUINCKE SPINAL NEEDLE
• 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: 16740492
• MDR Text Key: 313296102
• Report Number: 2618282-2023-00030
• Device Sequence Number: 1
• Product Code: BSP
• UDI-Device Identifier: 00382904051808
• UDI-Public: 00382904051808
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 04/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 405180
• Device Lot Number: 2224634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2022
• 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
• Patient Outcome(s): Other