MAUDE Adverse Event Report: EXT SET 0.2 MICRON FILTER SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number 20027E

Device Problems Backflow (1064); Obstruction of Flow (2423)

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the ext set 0.2 micron filter ss dehp free experienced flow issues.The following information was provided by the initial reporter: they are claiming that lipids are now backing up into the filter.

Manufacturer Narrative

H.6.Investigation: no product or photo was returned by the customer.It was reported that the lipids are backing up into the filter.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 20027e 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 the ext set 0.2 micron filter ss dehp free experienced flow issues.The following information was provided by the initial reporter: they are claiming that lipids are now backing up into the filter.

• Brand Name: EXT SET 0.2 MICRON FILTER SS DEHP FREE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12471034
• MDR Text Key: 271540890
• Report Number: 9616066-2021-52048
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403234857
• UDI-Public: 50885403234857
• Combination Product (y/n): N
• PMA/PMN Number: K960280
• 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: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 20027E
• Device Catalogue Number: 20027E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2021
• 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