MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA 5 ML BD PLASTIPAK LUER-SLIP SYRINGE

Catalog Number 990317

Device Problem Packaging Problem (3007)

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reported addr 1: (b)(6).Investigation summary: evaluating the images provided it was possible to observe empty packaging and loose parts.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.According to the investigation carried out, a possible cause of the defect could have been operational failure when packaging the product.The operator put the discarded packaging together with the material and did not see that a loose part without packaging was in the box.We inform that the current controls to detect the incident are performed through visual inspection in the packaging process.The operators of the production line will be notified of the occurrence.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.Investigation conclusion: checked the quality notifications and maintenance records, and found no potential records related to the failure.However, it was possible to confirm the deviation through the analysis of the photo sent by the customer.The operators of the production line will be notified of the occurrence, it will be registered in the note: (b)(4).

Event Description

It was reported that 10 5 ml bd plastipak¿ luer-slip syringes experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: product's package is empty, and one syringe loose without package inside the sealed box.

• Brand Name: 5 ML BD PLASTIPAK LUER-SLIP SYRINGE
• 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: 11691103
• MDR Text Key: 272030022
• Report Number: 3003916417-2021-00081
• 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: 04/13/2021

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: 990317
• Device Lot Number: 0120083
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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