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

Catalog Number	303370
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.(b)(6).Device manufacture date: unknown.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 blood after injection.
Additional Manufacturer Narrative
Investigation summary: three photos and one loose lever lock sample were received and visually evaluated.The photos depict a loose lever lock body next to a bagged injection tubing apparently filled with blood.The lever lock sample was visually inspected.It was confirmed to be from mold/cavity x-86.No molding defects were found in any parts of the sample returned.Lot number is unknown; therefore dhr could not be performed.No visual defects were observed in the lever lock body.The lever lock sample was tested for leakage.No leakage was found at any point within the body of the sample.The reported defect was not identified in the samples received.
Event or Problem Description
It was reported that the bd¿ interlink® lever lock cannula leaked blood after injection.

• 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: 8206278
• Report Number: 1213809-2018-00948
• Device Sequence Number: 16619658
• 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): 04/09/2019

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: 303370
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 04/09/2019
• 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