MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 15 G BD¿ INTERLINK® LEVER LOCK CANNULA; NEEDLELESS IV CONNECTION SYSTEM

Catalog Number	303370
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation : investigation summary: lot number history review / dhr review.Lot number unknown; therefore lot history and dhr review could not be performed.Based on no photo/ no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failure.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 : lot number history review / dhr review lot number unknown; therefore lot history and dhr review could not be performed.Based on no photo/ no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failure.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.Root cause description: no root cause can be determined as no samples or photos were received.
Event or Problem Description
It was reported that a bd 15 g bd¿ interlink® lever lock cannula was found leaking.It is unknown when the leakage occurred.No report of injury or medical intervention was reported.

• Brand Name: 15 G BD¿ INTERLINK® LEVER LOCK CANNULA
• Common Device Name: NEEDLELESS IV CONNECTION SYSTEM
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 6989196
• Report Number: 1213809-2017-00236
• Device Sequence Number: 16531355
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K940697
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/19/2017

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: 303370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2016
• Initial Report FDA Received Date: 10/30/2017
• 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