MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD SPINAL NEEDLE 27GA 3-1/2IN

Catalog Number 408381

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

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 the spinal needle is unable to thread through introducer needle with a bd spinal needle 27ga 3-1/2in.The following information was provided by the initial reporter, translated from (b)(6) to english: doctors reports that the needle is thin and does not thread as before.

Event Description

It was reported that during use the spinal needle is unable to thread through introducer needle with a bd spinal needle 27ga 3-1/2in.The following information was provided by the initial reporter, translated from portuguese to english: doctors reports that the needle is thin and does not thread as before.

Manufacturer Narrative

H.6.Investigation: no photos or physical samples that display the reported condition were available for investigation.Product undergoes inspections throughout manufacturing to ensure the quality of the device, including visual inspections to evaluate any defects on the cannula, verify external and internal diameters of the cannula, and to verify there is no damage on the hub thread.A device history review was performed for reported lot 9058939, no deviations or non-conformances were identified during the cannula manufacturing process that could have contributed to this issue.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

• Brand Name: BD SPINAL NEEDLE 27GA 3-1/2IN
• Type of Device: SPINAL NEEDLE
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 9587279
• MDR Text Key: 190684109
• Report Number: 9610048-2019-00368
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/26/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 408381
• Device Lot Number: 9058939
• Initial Date Manufacturer Received: 12/27/2019
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 12/27/2019
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other