MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPACK¿ SYRINGE

Catalog Number 990172

Device Problem Positioning Problem (3009)

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

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 bd plastipack¿ syringe stopper of the plunger was out of place.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: batch history (dhr) analysis, maintenance records and quality notifications were performed and no deviation was found for this lot.No photos / samples were taken by the client for evaluation, it was not possible to carry out an investigation and determine the root cause for the incident.The production processes are validated according to the defined acceptance criteria.In this way it is not possible to confirm the complaint.

Event Description

It was reported that bd plastipack¿ syringe stopper of the plunger was out of place.No serious injury or medical intervention was reported.

• Brand Name: BD PLASTIPACK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8112268
• MDR Text Key: 128747901
• Report Number: 3003916417-2018-00332
• 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
• 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: 11/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 990172
• Device Lot Number: 8198665
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other