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

Model Number	303370
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: two photos of a lever lock cannula in a fully sealed blister pack from batch 8323958 (p/n (b)(4)) were received and evaluated.It was observed there was a cluster of black foreign matter particles outside the fluid path.The particles appeared to be attached to the bottom web of the package as well as the top and middle of the hub.The composition of the foreign matter could not be determined based on the photo but at least one particle was large enough in size to be rejectable per product specification.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.Investigation conclusion: 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: potential root cause for the foreign matter defect is likely associated with the packaging process.Rationale: no corrective actions are necessary based on the defective rate identified.
Event or Problem Description
It was reported that cannula interlink lever lock had foreign matter.The following information was provided by the initial reporter: debris noticed in unopened sterile packaging.Dirt found inside unopened product.

• Brand Name: CANNULA INTERLINK LEVER LOCK
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11263592
• Report Number: 1213809-2021-00048
• Device Sequence Number: 11577339
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2021
• Device Model Number: 303370
• Device Catalogue Number: 303370
• Device Lot Number: 8323958
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1