MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE SOLOMED 5ML LL 22X1 W/SH SLA

Catalog Number 302630

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 07/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation summary: the analysis of samples sent by the customer (3 samples) was carried out.Through the analysis, it was possible to observe the incident of difficulty in moving the plunger.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.All samples had silicone inside the syringe, but it was poorly spread, which caused difficulty in moving the plunger.Investigation conclusion: 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.Root cause description: the possible cause of the incident is a failure of the siliconizing nozzle.

Event Description

It was reported that syringe solomed 5ml ll 22x1 w/sh sla plunger was difficult to move.The following information was provided by the initial reporter: resistance in use.They do not have the lubrication they should have to slide the syringe plunger.

• Brand Name: SYRINGE SOLOMED 5ML LL 22X1 W/SH SLA
• Type of Device: 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: 12509142
• MDR Text Key: 272578653
• Report Number: 3003916417-2021-00296
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302630
• Device Lot Number: 0105469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2020
• 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