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	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: dhr review was performed.Model: a2-80072 lot number: 20076342 qty: (b)(4) qn/deviations: zero mfg date: jul/19/2020 *no qns were found for the reported lot.Trend review: a trend review was performed for model a2-80072 and no qns related to this failure mode were found in a 12-months period (september 22nd, 2020 to september 22nd, 2021).A trend review was performed for model a2-80072 and one additional complaint (b)(4) related to this failure mode was found in a 12-months period (september 22nd, 2020 to september 22nd, 2021).Investigation summary: sample for the reported failure mode was requested, however, on september 22nd , 2021, was confirmed that no samples will be received, therefore, no investigation was performed since no samples or picture was received for evaluation and no further information regarding to the failure was provided from customer.Root cause definition: no root cause definition was determined due to the customer not providing a sample for evaluation and no further information was provided.Corrective and preventive actions: no preventive and corrective actions required since the failure mode could not be confirmed.We will continue to monitor our customer feedback processes for any similar incidences, implement any corrective actions as appropriate.
Event or Problem Description
It was reported that the 105" admin set 20 dp, w/2 y site, cv was clogged.The following information was provided by the initial reporter: stated that an administration set model a2-80072 lot 20016342 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: 12625963
• Report Number: 9616066-2021-52214
• Device Sequence Number: 5936961
• 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
• Report Date (Section B): 09/16/2021

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: 01/16/2023
• Device Catalogue Number: A2-80072
• Device Lot Number: 20076342
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 10/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2020
• 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