MAUDE Adverse Event Report: BD SWITZERLAND EU HQ AS LVP 20D DEHP 3SS 2G-4WSPK CV; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10013034
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6), usa has been used as a default.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of air in the tubing could not be verified due to the product not being returned for failure investigation.Device history record review could not be performed on model 10013034 because a lot number was not provided by the customer.Root cause analysis: the root cause of this failure was not identified as no product was returned.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that as lvp 20d dehp 3ss 2g-4wspk cv had air in the line during use.The following information was provided by the initial reporter: material no.: 10013034 batch no.: unknown it was reported there was air in the tubing.I am the clinician that works with the alaris pump tubing.I just left a voicemail and wanted to follow up with an email as well.I am sorry that your facility is experiencing so many air in line issues with our tubing.

• Brand Name: AS LVP 20D DEHP 3SS 2G-4WSPK CV
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD SWITZERLAND EU HQ; terre bonne park ¿ a4; route de crassier 17; 1262 eysins, ; SZ
• MDR Report Key: 10179702
• Report Number: 9616066-2020-01960
• Device Sequence Number: 2680705
• Product Code: FPA
• UDI-Device Identifier: 10885403232312
• UDI-Public: 10885403232312
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 10013034
• Device Catalogue Number: 10013034
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2020
• 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