MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PRECISIONGLIDE NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	310216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	10/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone #: (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 or Problem Description
It was reported while using bd precisionglide needle an adverse reaction occurred.The following information was provided by the initial reporter, translated from portuguese to english: customer contacted yesterday (10/31) claiming that three patients (babies) suffered an adverse reaction such as non-infectious anaphylactic shock, that is, a reaction due to something chemical.The institution opened a notification with the health surveillance.This is patient 2 of 3.Was there any harm to the patient? the patients involved progressed to cardiorespiratory arrest requiring orotracheal intubation and advanced life support.Was there a need for medical and/or surgical intervention due to the event (imaging exams, surgery, medication administration, etc)? the patients involved progressed to cardiorespiratory arrest requiring orotracheal intubation and advanced life support.They did not require surgery, but due to the severity they required advanced intensive care support.What medication was being administered? 10% glucose serum.There was also the use of saline solution 09% to wash the access.(the serum manufacturer was also notified and we followed the same evaluation process with this material).
Additional Manufacturer Narrative
Since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Additionally, catalog history was ran, no related complaint for failure' reaction/allergic.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.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.
Event or Problem Description
No additional information.

• Brand Name: BD PRECISIONGLIDE NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15859399
• Report Number: 3003916417-2022-00275
• Device Sequence Number: 20294950
• Product Code: FMI
• UDI-Device Identifier: 00382903051366
• UDI-Public: 00382903051366
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Catalogue Number: 310216
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2022
• Supplement Date Received by Manufacturer: 01/03/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown