MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 10ML CLEAR STERILE; GASTROINTESTINAL TUBE AND ACCESSORIES

Catalog Number	305857
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.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.Investigation conclusion: 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.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 the syringe oral 10ml clear sterile experienced leakage.

• Brand Name: SYRINGE ORAL 10ML CLEAR STERILE
• Common Device Name: GASTROINTESTINAL TUBE AND ACCESSORIES
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8354375
• Report Number: 1213809-2019-00243
• Device Sequence Number: 19266125
• Product Code: KNT
• UDI-Device Identifier: 30382903058571
• UDI-Public: 30382903058571
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2019

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: 305857
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/20/2019
• 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