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 Patient Involvement (2645)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: one photo of a lever lock cannula attached to an unknown adapter was received and evaluated.It was observed the cannula contained multiple reddish embedded foreign matter particles throughout the body.The particles appeared to burnt plastic, which were 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.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 embedded foreign matter defect is associated with the molding process.The embedded foreign matter is most likely degraded plastic.This occurs when the resin is exposed to prolonged high temperatures inside the molding machine, such as during start up.Per procedure, after start up, all molded parts are scrapped until no degraded plastic is observed.If this is not performed thoroughly a piece with this condition can get through.This type of defect is cosmetic and does not pose risk to the customer.Rationale: no corrective actions are necessary based on the defective rate identified.Batch 8270716 is considered in compliance with our product specification requirements.
Event or Problem Description
It was reported that cannula interlink lever lock had foreign matter under the cap.This was discovered before use.The following information was provided by the initial reporter: the report is that our customer has found red spots / splashes under the protective cap.Unfortunately i only have a photo available where this is clearly visible.

• 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: 10505214
• Report Number: 1213809-2020-00606
• Device Sequence Number: 2962013
• Product Code: FPA
• UDI-Device Identifier: 30382903033707
• UDI-Public: 30382903033707
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 08/19/2020

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: 09/30/2021
• Device Model Number: 303370
• Device Catalogue Number: 303370
• Device Lot Number: 8270716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/08/2020
• 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