MAUDE Adverse Event Report: AS LVP 20D 1.2M; INTRAVASCULAR ADMINISTRATION SET

Model Number	2207-0007
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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 or Problem Description
It was reported that the gem v/nv 20d no port wouldn't prime due to flow issues/blockage.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "i'm not certain but i believe they have had 7 more instances of the iv set not priming past the 1.2 micron filter.".
Event or Problem Description
It was reported that the as lvp 20d 1.2m wouldn't prime due to flow issues/blockage.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "i'm not certain but i believe they have had 7 more instances of the iv set not priming past the 1.2 micron filter.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 20115719 d.4.Medical device expiration date: 11/4/2023 h.4.Device manufacture date: 11/4/2020 d.4.Medical device lot #: 20105929 d.4.Medical device expiration date: 10/7/2023 h.4.Device manufacture date: 10/7/2020 d.4.Medical device lot #: 20105914 d.4.Medical device expiration date: 10/8/2023 h.4.Device manufacture date: 10/6/2020 d.4.Medical device lot #: 20096797 d.4.Medical device expiration date: 9/21/2023 h.4.Device manufacture date: 9/19/2020 d.4.Medical device lot #: unknown d.4.Medical device expiration date: unknown h.4.Device manufacture date: unknown the following fields were updated due to corrected information: b.5.Describe event or problem: it was reported that the as lvp 20d 1.2m wouldn't prime due to flow issues/blockage.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "i'm not certain but i believe they have had 7 more instances of the iv set not priming past the 1.2 micron filter." d.1.Medical device brand name: as lvp 20d 1.2m d.4.Medical device catalog #: 2202-0007 d.4.Unique identifier (udi) #: (b)(6) g.4.Pma / 510(k)#: k944320 h.6.Investigation: 80 unused samples were returned for investigation.The sets were examined for defects and abnormalities.No other defects or abnormalities were observed.Set was attached to an iv bag filled with blue dye water and allowed to prime using gravity.Set was successfully primed.Sets were then attached to an iv bag filled with 85% glycerin/ 15% water and allowed to prime using gravity.The samples primed as expected.The customer complaint that there were 7 more instances of iv sets not priming past the 1.2 micron filter could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model 2202-0007 lot number 20115719 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2202-0007 lot number 20105929 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2202-0007 lot number 20105914 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 2202-0007 lot number 20096797 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.

• Brand Name: AS LVP 20D 1.2M
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11624974
• Report Number: 9616066-2021-50671
• Device Sequence Number: 3668110
• Product Code: FPA
• UDI-Device Identifier: 50885403463950
• UDI-Public: 50885403463950
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: 2207-0007
• Device Catalogue Number: 2202-0007
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 04/06/2021
• Supplement Report FDA Received Date: 08/25/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1