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	01/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 with the use of the bd¿ interlink® lever lock cannula there was an issue with red foreign matter on the product.
Event or Problem Description
It was reported with the use of the bd¿ interlink® lever lock cannula there was an issue with red foreign matter on the product.
Additional Manufacturer Narrative
Investigation summary: four photos and one interlink cannula in an opened blister pack from batch #7270829 (p/n 303370) were received and evaluated.It was observed the photos displayed the physical sample.Three embedded foreign matter particles were present in the sample.They are reddish in color and located near the top of the hub.One of the particles is larger than level 3 in size, which is rejectable per product specification.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.Potential root cause for the embedded foreign matter defect is associated with the molding process.No corrective actions are necessary based on the defective rate identified.

• 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: 8329485
• Report Number: 1911916-2019-00162
• Device Sequence Number: 1527744
• 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): 04/18/2019

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: 09/30/2020
• Device Catalogue Number: 303370
• Device Lot Number: 7270829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 01/24/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 04/18/2019
• 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