MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ INTERLINK® LEVER LOCK CANNULA; INTERLINK SYSTEM CANNULA

Catalog Number	303370
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on (b)(6) 2018 via medwatch (b)(4).A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd¿ interlink® lever lock cannula leaked during use.There was no report of exposure, injury or medical interventions.
Additional Manufacturer Narrative
Investigation summary: lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Since no samples displaying the condition reported are available for examination, bd was unable to fully investigate this incident.No root cause can be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.Based on no sample, the investigation concluded: unconfirmed: bd was not able to confirm the customer¿s indicated failures.Investigation conclusion: no root cause can be determined as no samples were received.

• Brand Name: BD¿ INTERLINK® LEVER LOCK CANNULA
• Common Device Name: INTERLINK SYSTEM CANNULA
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7323967
• Report Number: 1213809-2018-00088
• Device Sequence Number: 18869874
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: Nurse
• Device Catalogue Number: 303370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2018
• Supplement Date Received by Manufacturer: 02/14/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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
• Patient Age: 50 YR