MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANESTHESIA TRAY BASIC SPINAL; SYRINGE

Catalog Number 401383

Device Problem Packaging Problem (3007)

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

Event Date 07/17/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter fax#: (b)(6).Investigation summary: 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, 0356289, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the package had the correct manufacturing marks.The seal was completed using thermal transfer and the material line did not leave the production line open.It was also noted that the folding of the surgical field shown in the photo does not follow the specified production standards, concluding that the product was removed from the packaging, handled and returned to the original envelope, but without the original folding condition that could only be replicated on the production line.Therefore, based off the evidence seen in the provided photo the engineer was unable to verify the reported issue.The photo showed evidence that a proper seal was placed and that the package had been handled after release contributing to the reported issue.Investigation conclusion: complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Root cause description: the engineer could not identify any manufacturing related issue in the provided photo.For a more thorough investigation the package would have to be returned to the manufacturing facility for analysis.The manufacturing facility has been notified of this incident and the findings.Rationale: collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.

Event Description

It was reported that anesthesia tray basic spinal was damaged.The following information was provided by the initial reporter: packaging presents closing defect.The part that should be sealed was detached, contaminating the product.

• Brand Name: ANESTHESIA TRAY BASIC SPINAL
• Type of Device: SYRINGE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12318655
• MDR Text Key: 268020651
• Report Number: 9610048-2021-00115
• Device Sequence Number: 1
• Product Code: FMF
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 401383
• Device Lot Number: 0356289
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2021
• 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