MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SPINAL NEEDLE QUINCKE TYPE POINT; ANESTHETIC CONDUCTION NEEDLE

Catalog Number 405259

Device Problem Leak/Splash (1354)

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

Event Date 06/22/2023

Event Type  malfunction  

Event Description

It was reported that during use with bd spinal needle quincke type point medication leaked at luer connection.The following information was provided by the initial reporter, translated from spanish to english: matching the syringe with the medication spills the anesthetic.

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 during use with bd spinal needle quincke type point medication leaked at luer connection.The following information was provided by the initial reporter, translated from spanish to english: matching the syringe with the medication spills the anesthetic.

Manufacturer Narrative

H6: investigation summary no photos or physical samples that display the reported condition were provided to our quality team for investigation.A device history review was performed for lot 2111012, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected, no damage or defects were observed on or near the luer connection.Functional testing was performed, connecting the needle to a syringe.Liquid was able to pass from the syringe through the needle and no leakage was observed.Product is visually and functionally tested throughout manufacturing according to procedure, verifying all critical dimensions are within specification.Testing results for lot 2111012 verified product met all required limits.Based on the available information we are not able to identify a root cause at this time.

• Brand Name: BD SPINAL NEEDLE QUINCKE TYPE POINT
• Type of Device: ANESTHETIC CONDUCTION NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17337994
• MDR Text Key: 319896807
• Report Number: 3003152976-2023-00288
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

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 Catalogue Number: 405259
• Device Lot Number: 2111012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/11/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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