MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML LL; PISTON SYRINGE

Model Number	305283
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #: 73349676 does not match with the reported medical device catalog # so the manufacture and expiration dates are unknown.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 has been reported that the syringe integra 3ml ll has been found experiencing leakage during use.The following has been provided by the initial reporter: it was reported that leakage at the luer connection has happened more than a dozen times while administering the flu vaccine.Per email: there has been noted leakage at the connection of the needle and syringe, as of today (october 25th) more than a dozen have been leaking at the connection site.
Event or Problem Description
It has been reported that the syringe integra 3ml ll has been found experiencing leakage during use.The following has been provided by the initial reporter: it was reported that leakage at the luer connection has happened more than a dozen times while administering the flu vaccine.Per email: there has been noted leakage at the connection of the needle and syringe, as of today (october 25th) more than a dozen have been leaking at the connection site.
Additional Manufacturer Narrative
H.6.Investigation summary: since no samples 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.A device history record review could not be performed as lot number provided is not a bd batch # recognized in the system.It is important to verify the needle is tightly connected to the syringe prior to use per the ifu.Physical samples are required for investigation of any possible manufacturing defects.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.H3 other text : see section h.10.

• Brand Name: SYRINGE INTEGRA 3ML LL
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9355344
• Report Number: 1213809-2019-01161
• Device Sequence Number: 19586237
• Product Code: MEG
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2020

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?: Yes
• Operator of Device: Other
• Device Model Number: 305283
• Device Catalogue Number: 305283
• Device Lot Number: 73349676
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 02/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other