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

Catalog Number	303370
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd¿ interlink® lever lock cannula leaked.
Additional Manufacturer Narrative
Investigation summary: the samples were decontaminated and re-evaluated.The samples were from cavities 29 and x67.Slight opaqueness was observed near the luer end of both samples, however that is a cosmetic imperfection.The previously observed and perceived embedded foreign matter was not present, which indicates it was not embedded but was likely a result of use/manipulation by the end user and was removed during decontamination process.No visual defects were observed.Both samples were leak tested.Both passed ¿ no leakage was found at either end of the lever lock bodies.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.The reported defect was not identified in the samples received.No corrective actions are necessary based on the defective rate identified.
Event or Problem Description
It was reported that the bd¿ interlink® lever lock cannula leaked.

• Brand Name: BD¿ INTERLINK® LEVER LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8137910
• Report Number: 1213809-2018-00853
• Device Sequence Number: 1621062
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K940697
• 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): 02/26/2019

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 303370
• Device Lot Number: 7235683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 11/13/2018
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 02/26/2019
• 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