MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD SPINAL NEEDLE 26GA 3-1/2IN; ANESTHESIA CONDUCTION NEEDLE

Catalog Number 408380

Device Problem Packaging Problem (3007)

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

Event Date 10/23/2022

Event Type  malfunction  

Event Description

It was reported the the package unit for the bd spinal needle 26ga 3-1/2in was open, thus affecting sterility.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: customer would like to report one more incident regarding the material: package is opened, which made impossible to use it.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 the the package unit for the bd spinal needle 26ga 3-1/2in was open, thus affecting sterility.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: customer would like to report one more incident regarding the material: package is opened, which made impossible to use it.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-nov-2022.H6: investigation summary bd received a 26 gauge spinal needle from lot 1357421 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the needle was bent but could not identify any damage to the returned unit's packaging.The returned packaging was found to be intact and sealed even though the needle was bent inside.Therefore, based off the visual inspection the engineer was able to verify the reported defect of bent needle but could not identify any issues with the returned unit's packaging.It was determined that the bent needle was a manufacturing defect caused during the packaging process.

• Brand Name: BD SPINAL NEEDLE 26GA 3-1/2IN
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• 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: 15800885
• MDR Text Key: 306529591
• Report Number: 9610048-2022-00147
• 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: Initial,Followup
• Report Date: 01/18/2023

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: Health Professional
• Device Catalogue Number: 408380
• Device Lot Number: 1357421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2022
• Initial Date FDA Received: 11/15/2022
• Supplement Dates Manufacturer Received: 01/18/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2022
• 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