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

Catalog Number 302632

Device Problem Leak/Splash (1354)

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

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

(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 solomed¿ needle there was an issue with medication leakage from stopper of plunger.

Manufacturer Narrative

Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The sample sent by the customer were verified and it was possible to observe barrel damaged, which caused the leakage during the syringe usage.The potential cause for the occurrence is a jam on assembly machine system, which caused the barrel damage.The incident identified from this complaint will be monitored for trend evaluation.

Event Description

It was reported with the use of the bd solomed¿ needle there was an issue with medication leakage from stopper of plunger.

• Brand Name: BD SOLOMED¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8203797
• MDR Text Key: 131716208
• Report Number: 3003916417-2018-00375
• 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: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 302632
• Device Lot Number: 8115988
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other