MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE WITH NEEDLE

Catalog Number 990146

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd plastipak¿ syringe with needle there was an issue with needle separation.There was no report of injury or medical intervention.

Manufacturer Narrative

The batch history analysis was performed, quality notifications were verified, maintenance records.It was found a maintenance record (b)(4) and are related to the defect.Photographs and samples of the needle were made available for analysis in which it was possible to confirm the defect of loose cannula.A loose cannula was found without the resin epoxy in the hub component.We verified that the hub had flash at the tip of the nozzle above the specified one.The defect may have occurred due to a mold defect.The probable cause for the defect is related to the flash presented at the tip of the hub nozzle that prevents the applicator nozzle from filling the cannula housing.The flash is caused by excessive slack between the mold components.A corrective maintenance order was opened for the exchange and adjustment of the mold components.

Event Description

It was reported with the use of the bd plastipak syringe with needle there was an issue with needle separation.There was no report of injury or medical intervention.

• Brand Name: BD PLASTIPAK¿ SYRINGE WITH NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7953635
• MDR Text Key: 123373734
• Report Number: 3003916417-2018-00258
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 990146
• Device Lot Number: 8113651
• Date Manufacturer Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other