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

Catalog Number 302633

Device Problems Air Leak (1008); Break (1069); Fluid/Blood Leak (1250); Defective Component (2292); Aspiration Issue (2883)

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

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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.

Event Description

It was reported that when using bd solomed¿ syringe(s) multiple defects occur such as leaking, broken syringe and ¿aspirating more air then medicine¿.There was no report of treatment changes exposure, injury or medical interventions.

Manufacturer Narrative

Investigation results: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.Analysis of batch history: lot 7072702 was produced from 08 / apr / 2017 to 13 / apr / 2017.Lot 7072706 was produced from 25 / apr / 2017 to 27 / apr / 2017.The inspections carried out on the product were verified and no records of the claimed defect in the batch history were evidenced.The inspections performed on the moij 52 injection molding machine and bh-03 mold were checked and there is evidence of corrective maintenance.However, it is not possible to confirm that the correction is related to the defect without sample analysis.Before the batch is released to the consumer, the product still goes through the process of evaluation of the final inspection laboratory, where more validated visual tests are performed, certifying the conformity of the product.After reviewing this document, it can be verified that all the tests performed were within the specifications of the product.No record was found that could lead to this defect.Capa is not required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SOLOMED¿ SYRINGE
• Type of Device: HYPODERMIC SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7436863
• MDR Text Key: 105919617
• Report Number: 3003916417-2018-00060
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302633
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other