MAUDE Adverse Event Report: AS LVP 20D 3SS CV BV; INTRAVASCULAR ADMINISTRATION SET

Model Number 11522558

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that as lvp 20d 3ss cv bv had air in the line.The following information was provided by the initial reporter: it was reported that the "blue ball tubing" is "sucking air".

Manufacturer Narrative

The following fields were updated due to corrected information: d.9.Device available for eval?: no.D.9.Returned to manufacturer on: na.H.6.Investigation: no product or photo was returned by the customer.The customer complaint that the "blue ball tubing" is "sucking air" could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.

Event Description

It was reported that as lvp 20d 3ss cv bv had air in the line.The following information was provided by the initial reporter: it was reported that the "blue ball tubing" is "sucking air".

• Brand Name: AS LVP 20D 3SS CV BV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11925679
• MDR Text Key: 263539063
• Report Number: 9616066-2021-51239
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403232303
• UDI-Public: 50885403232303
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 11522558
• Device Catalogue Number: 11522558
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/10/2021
• Date Manufacturer Received: 09/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1