MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK SYRINGE 10ML LUER-LOK; PISTON SYRINGE

Catalog Number 990172

Device Problem Illegible Information (4050)

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

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter first name: (b)(6).Investigation summary: through the analysis of the photo sent by the customer, it is possible to observe the illegible printed batch.The analysis of the batch history (dhr), maintenance records and quality notifications were verified and no deviation was found for this batch.The label review record, which is carried out to ensure correct printing of information, was analyzed and no defects were found.No request for reprinting of labels related to the claimed box was evidenced.The possible cause for the incident was an entanglement of the box in the part of the equipment that pulls the box for closing.As corrective action, bd has a project to change the design of the equipment with the change in the box's traction system.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd plastipak¿ syringe 10ml luer-lok¿ had the label smeared such that it was illegible.The following information was provided by the initial reporter: "during the receipt, it was identified one box with quality issue (batch # is unreadable).".

• Brand Name: BD PLASTIPAK SYRINGE 10ML LUER-LOK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12507221
• MDR Text Key: 272499943
• Report Number: 3003916417-2021-00294
• 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: 09/06/2021

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: 990172
• Device Lot Number: 1168995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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