MAUDE Adverse Event Report: 105" ADMIN SET 20 DP, W/2 Y SITE, CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	A2-80072
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	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 105" admin sets 20 dp, w/2 y site, cv had flow issues and were blocked/occluded while priming them.The following information was provided by the initial reporter: "received an email stated that an administration set model a2-80072, lot 20095073 set would not prime.Operator (b)(6).Medication n/a.Patient involved.Patient was not harmed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 8/9/2021.H.6.Investigation: 3 samples of the model a2-80072 were received, the samples were visually inspected, and no issues were observed during the inspection.The three samples were tested, and no occlusion issues were found in two (2) of them, however, for the remaining sample, the occlusion was evident due to no flow was observed between the drip chamber and the tubing, confirming the occlusion in the set.The occluded set was reviewed with the process quality engineer, and it was decided to cut the set to identify where the occlusion is, the set was cut in the bottom side of the drip chamber near to the valve, and the occlusion between the drip chamber and the tubing was not observed.Since the occlusion was not observed between the tubing and the drip chamber after the cut, the valve check was tested, and the occlusion was confirmed.A revision of 3 samples of the model a2-80072 was conducted, and one samples was found to be occluded, the samples was cut in the parts to verify where the occlusion was, however, during the verification, it was confirmed that the occlusion in the a2-80072 was related to the check valve.Dhr was performed and no qn's were found.H3 other text : see h.10.
Event or Problem Description
It was reported that 3 105" admin sets 20 dp, w/2 y site, cv had flow issues and were blocked/occluded while priming them.The following information was provided by the initial reporter: "received an email stated that an administration set model a2-80072 lot 20095073 set would not prime.Operator rn.Medication n/a.Patient involved.Patient was not harmed.".

• Brand Name: 105" ADMIN SET 20 DP, W/2 Y SITE, CV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12340466
• Report Number: 9616066-2021-51831
• Device Sequence Number: 4535672
• Product Code: FPA
• UDI-Device Identifier: 00814371020112
• UDI-Public: 00814371020112
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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: Health Professional
• Device Expiration Date: 09/03/2023
• Device Catalogue Number: A2-80072
• Device Lot Number: 20095073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2021
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 10/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/24/2020
• 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