MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD EMERALD¿ SYRINGE FOR GENERAL PURPOSE USE; SYRINGE WITH NEEDLE

Catalog Number 302981

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/29/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that after administering a vaccine to a child, the needle on the bd emerald¿ syringe for general purpose use detached and remained in the child¿s leg.There was no report of injury or medical interventions.

Manufacturer Narrative

Complaint not confirmed.Without samples or photos it was not possible determine the root cause.It was performed a batch and process analysis, but it was not found any occurrence that could be generated the defect informed by the customer.The complaint will be monitoring to evaluate the tendency analysis.Without samples or photos it was not possible determine the root cause.It was performed a batch and process analysis, but it was not found any occurrence that could be generated the defect informed by the customer.

• Brand Name: BD EMERALD¿ SYRINGE FOR GENERAL PURPOSE USE
• Type of Device: SYRINGE WITH NEEDLE
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6887366
• MDR Text Key: 89390932
• Report Number: 3003916417-2017-00044
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 302981
• Device Lot Number: 6097377
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2016
• 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
• Patient Outcome(s): Other