MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK 10ML SYRINGE SLIP TIP

Catalog Number 990558

Device Problem Packaging Problem (3007)

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

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter:(b)(6).Investigation summary: after the evaluation of the received photos and the photo characteristic, this failure happened due to an incorrect setup, where the operator did not empty the feeder to make the paper change in the sealing station of the machine.The retention samples were evaluated and no failure was observed.Batch history analysis was performed, quality notifications and maintenance records were checked where no records potentially related to failure were found.The operators of the production line will be notified about 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: batch history analysis was performed, quality notifications and maintenance records were checked where no records potentially related to failure were found.The retention samples were evaluated and no failure was observed.After the evaluation of the received photos and the photo characteristic, this failure happened due to an incorrect setup, where the operator did not empty the feeder to make the paper change in the sealing station of the machine.The operators of the production line will be notified about the occurrence.Notification will be registered in the note: (b)(4).Additionally the incident identified from this complaint will be monitored for trend assessment.

Event Description

It was reported that 8 bd plastipak¿ 10ml syringe slip tips experienced damaged or open unit packaging/seals where sterility was compromised.The following information was provided by the initial reporter: product double labeled, but the package hasn't been sealed, letting the syringes open.

• Brand Name: BD PLASTIPAK 10ML SYRINGE SLIP TIP
• 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: 11646112
• MDR Text Key: 247260363
• Report Number: 3003916417-2021-00075
• 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: 04/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990558
• Device Lot Number: 0329782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• 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