MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405259

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2023

Event Type  malfunction  

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 Description

It was reported that the bd¿ spinal needle leaked medication between the needle and syringe hub during the spinal block procedure.The following information was provided by the initial reporter: "after the procedure block the patient's back with spinal 27g and continue the syringe to inject drug the patient.Found that the drug was dripping directly between the needle joint and the syringe (hub) causing problems in spinal block operation.The patient did not receive the full dose, causing the need to add more medication.This increases the risk of total spinal block in patients.The number of cases found 1 box".

Event Description

It was reported that the bd¿ spinal needle leaked medication between the needle and syringe hub during the spinal block procedure.The following information was provided by the initial reporter: "after the procedure block the patient's back with spinal 27g and continue the syring to inject drug the patient.Found that the drug was dripping directly between the needle joint and the syringe (hub) causing problems in spinal block operation.The patient did not receive the full dose, causing the need to add more medication.This increases the risk of total spinal block in patients.The number of cases found 1 box".

Manufacturer Narrative

H6: investigation summary photo received by our quality team for investigation.Upon visual evaluation, product box is displayed with lot number 2204021, unable to confirm failure based on images.A device history review was performed for lot 2204021, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples from the same lot were evaluated, no defects or issues observed.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.

Manufacturer Narrative

H.6.Investigation summary: photo received by our quality team for investigation.Upon visual evaluation, product box is displayed with lot number 2204021, unable to confirm failure based on images.Additionally, samples were received.No defects or issues observed.Further testing was conducted, no sign of leakage occurred.A device history review was performed for lot 2204021, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples from the same lot were evaluated, no defects or issues observed.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.Bd recommends using luer lock syringes for these procedures because it is easier and the needle is better attached to the syringe with luer lock syringes.With this type of syringes, as they are by thread, there is no need to force the insertion, it can be easier, causing less discomfort to the patient and achieving a better union.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.Complaints received for this device and defect will be monitored by our quality team for signs of emerging trends.

Event Description

It was reported that the bd¿ spinal needle leaked medication between the needle and syringe hub during the spinal block procedure.The following information was provided by the initial reporter: "after the procedure block the patient's back with spinal 27g and continue the syring to inject drug the patient.Found that the drug was dripping directly between the needle joint and the syringe (hub) causing problems in spinal block operation.The patient did not receive the full dose, causing the need to add more medication.This increases the risk of total spinal block in patients.The number of cases found 1 box.".

• Brand Name: BD¿ SPINAL NEEDLE
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16765694
• MDR Text Key: 313565521
• Report Number: 3002682307-2023-00102
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/10/2023

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: Lay User/Patient
• Device Catalogue Number: 405259
• Device Lot Number: 2204021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 05/31/2023; 07/10/2023
• Supplement Dates FDA Received: 06/10/2023; 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2022
• 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