MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PRECISIONGLIDE NEEDLE

Catalog Number 300017

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Information (3190)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (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 that before use of the bd¿ precisionglide¿ needle the packages are partially opened, the bar code could not be used and the needles are out of the package.

Event Description

It was reported that before use of the bd¿ precisionglide¿ needle the packages are partially opened, the bar code could not be used and the needles are out of the package.

Manufacturer Narrative

Investigation summary: it was performed the dhr, there wasn¿t quality notification and only one maintenance record was found related with this failure and batch.The pictures of product were sent by the customer, with that was possible performing an investigation, confirming the failure and determine the probable root cause.We inform that there are controls to avoid this kind of failure, visual inspection each 02 hours with sample size of 40 pieces during the packing process.Moreover the vision system check 100% of batch if it has needle in the packaged, and the inspectors do the inspection by visual in sample of batch during the manufacture process.This failure will be monitored for evaluation of its tendency.

• Brand Name: BD PRECISIONGLIDE NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8366861
• MDR Text Key: 137421605
• Report Number: 3003916417-2019-00144
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 300017
• Device Lot Number: 8149502
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other