MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML BD INTEGRA SYRINGE

Catalog Number	305283
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.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.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.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.Investigation conclusion: based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Root cause description: no root cause can be determined as no samples were received.Rationale: capa is not required at this time.
Event or Problem Description
It was reported that 3 ml bd integra¿ syringe leaked from the hub of the syringe.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: material no: 305283, batch no: unknown.It was reported via medwatch report that the vaccine medication leaked from the hub of the syringe.Event description per attached medwatch report states, "while giving dtap injection i noticed medication squirted from the hub of the syringe.Background: patient was in for a 15 month checkup' this was a routine vaccination.Assessment: i informed md and she advised vaccine needed to be repeated, since i did notice that entire fluid was not administered.Recommendation: father agreed to the second dose' he himself noticed that all of the fluid came out of the syringe.Per md recommendation, dose was repeated.".

• Brand Name: 3 ML BD INTEGRA SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8535901
• Report Number: 1213809-2019-00457
• Device Sequence Number: 360592
• Product Code: FMF
• UDI-Device Identifier: 30382903052838
• UDI-Public: 30382903052838
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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 Catalogue Number: 305283
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2019
• Initial Report FDA Received Date: 04/22/2019
• 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