MAUDE Adverse Event Report: MSIII 20D DEHP 2SS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	28034E
Medical Device Problem Codes	Leak/Splash (1354); Free or Unrestricted Flow (2945)
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
Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that msiii 20d dehp 2ss sets weren't fitting in the pump and there was air in the line.The following information was provided by the initial reporter: it was reported that some sets do not fit in the pump.It was reported that there have been many air in line alarms for these sets.
Event or Problem Description
It was reported that msiii 20d dehp 2ss sets weren't fitting in the pump and there was air in the line.The following information was provided by the initial reporter: it was reported that some sets do not fit in the pump.It was reported that there have been many air in line alarms for these sets.
Additional Manufacturer Narrative
H.6.Investigation: one sample was received for quality investigation.The customer complaint of tubing defective / air in line could not be verified by testing.The infusion set was primed without air-in-line evident in the tubing.The infusion set was then installed into and msiii pump without and a simulated infusion conducted without a pump indication of air-in-line.The infusion sets submitted were primed and tested for fitment into an msiii infusion pump and the reported failure could not be replicated.A device history record review for model 28034e lot number 19115695 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause for the issue reported could not be determined because the reported failure could not be replicated during testing.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of tubing defective / air in line with lot #19115695 regarding item #28034e.H3 other text : see h.10.

• Brand Name: MSIII 20D DEHP 2SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12185990
• Report Number: 9616066-2021-51547
• Device Sequence Number: 16394032
• Product Code: FPA
• UDI-Device Identifier: 10885403274855
• UDI-Public: 10885403274855
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K874564
• 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): 09/13/2021

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 Catalogue Number: 28034E
• Device Lot Number: 19115695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2021
• Initial Date Received by Manufacturer: 06/17/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2019
• 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