MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD SPINAL¿NEEDLE; NEEDLE, CONDUCTION, ANESTETIC

Catalog Number 408380

Device Problem Packaging Problem (3007)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd spinal¿needle had the packaging tear leaving paper shards in the sterile field.The following information was provided by the initial reporter: it has been identified that when opening the package it tears, and doesn't open according to sterile way, leading to risk of contamination to product.

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0027609, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the package was torn.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, without a physical sample available for evaluation a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.

Event Description

It was reported that bd spinal¿needle had the packaging tear leaving paper shards in the sterile field.The following information was provided by the initial reporter: "it has been identified that when opening the package it tears, and doesn't open according to sterile way, leading to risk of contamination to product.".

• Brand Name: BD SPINAL¿NEEDLE
• Type of Device: NEEDLE, CONDUCTION, ANESTETIC
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13766101
• MDR Text Key: 287172405
• Report Number: 9610048-2022-00021
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: Followup
• Report Date: 04/05/2022

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: 408380
• Device Lot Number: 0027609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• 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