MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SPINAL NEEDLE 27GA 3.50 IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 405259

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 04/09/2022

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.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 27ga 3.50 syringe was loose and medication leaked.The following information was provided by the initial reporter, translated from spanish to english: "the syringe did not connect with the spinal needle, it was loose and the medicine spilled.".

Manufacturer Narrative

H6: investigation summary : no physical samples that display the reported condition were provided to our quality team for investigation.A device history review was performed for lot 2109018, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of the same lot were used for additional evaluation.The product was visually inspected, no damage or cracks 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 2109018 verified product met all required limits.Based on the available information we are not able to identify a root cause at this time.

Event Description

It was reported that the bd spinal needle 27ga 3.50 syringe was loose and medication leaked.The following information was provided by the initial reporter, translated from spanish to english: "the syringe did not connect with the spinal needle, it was loose and the medicine spilled.".

• Brand Name: BD SPINAL NEEDLE 27GA 3.50 IN
• Type of Device: ANESTHESIA 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 ; 8015296192
• MDR Report Key: 14595593
• MDR Text Key: 293463730
• Report Number: 3003152976-2022-00246
• 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,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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: 2109018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 06/03/2022
• Supplement Dates Manufacturer Received: 07/13/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2021
• 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
• Patient Age: 70 YR
• Patient Sex: Male