MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE 3ML BD LUER LOCK WITHOUT NEEDLE; PISTON SYRINGE

Catalog Number 990174

Device Problem Unsealed Device Packaging (1444)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default 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 10 bd syringes 3ml bd luer lock without needle had a damaged or open unit package.There is presence of adhesive tape on the packaging of the material.This favors the opening of the package during storage, making it impossible to use the material in a sterile way.Sterile syringe (10 units) with damaged packaging, there is a transparent fita adhesive on the packaging.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 18-may-2022.H6: investigation summary: a sample and photos were received.A device history record review showed no non-conformances associated with this issue during the production of this batch.A record of maintenance on the packaging machine, related to the defect complained about for this batch.The photos were made available by the customer for evaluation and allowed an investigation of the incident.The photos allow visualization of the damaged packaging defect, so it was possible to confirm the complaint.H3 other text : see h10.

Event Description

It was reported that 10 bd syringes 3ml bd luer lock without needle had a damaged or open unit package.There is presence of adhesive tape on the packaging of the material.This favors the opening of the package during storage, making it impossible to use the material in a sterile way.Sterile syringe (10 units) with damaged packaging, there is a transparent fita adhesive on the packaging.

• Brand Name: BD SYRINGE 3ML BD LUER LOCK WITHOUT NEEDLE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14177531
• MDR Text Key: 293696103
• Report Number: 3003916417-2022-00054
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990174
• Device Lot Number: 1048131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• 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