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	05/26/2020
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.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of air in line 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.A root cause could not be determined due to an investigation not being able to be performed.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.Root cause analysis: the root cause of this failure was not identified as no product was returned.Investigation conclusion: no product will be returned per customer.No investigation was performed.
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: we are having lots of trouble again with our stopcock tubing that is used on labor and delivery.Same issues as before it is always the air alarm when initiating the iv and we try diff pumps, different tubings (wasting many) and still can't get the iv pump to work.If we change it out to a primary tubing it works every time.We are throwing money away daily and frustrating many staff due to this issue.

• 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: 10163569
• Report Number: 9616066-2020-01976
• Device Sequence Number: 11490796
• Product Code: FPA
• UDI-Device Identifier: 10885403232312
• UDI-Public: 10885403232312
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/26/2020

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 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: 06/17/2020
• 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