MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 72-IN NON-DEHP MICROBOREE EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	ME2059
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/15/2020
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.(b)(4).
Event or Problem Description
It was reported that 5 72-in non-dehp microboree ext sets were clogged/blocked/occluded.The following information was provided by the initial reporter: rn used 5 different sets of syringe tubing bd maxguard extesion set , ref#me2059, lot #20047165 very difficult to prime with saline.Pump beeped occlusion the whole time while trying to infuse benedryl.
Event or Problem Description
It was reported that 5 72-in non-dehp microboree ext sets were clogged/blocked/occluded.The following information was provided by the initial reporter: rn used 5 different sets of syringe tubing bd maxguard extesion set , ref#me2059, lot #20047165 very difficult to prime with saline.Pump beeped occlusion the whole time while trying to infuse benedryl.
Additional Manufacturer Narrative
H.6.Investigation: 3 samples were returned by the customer.It was reported that 5 different extension sets had difficulty in priming with saline.The returned sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets were connected to a 10 ml syringe and attempted to be flushed with at least 10 ml of a blue dye/water mixture.The sets were able to be flushed.The failure was unable to be replicated.A device history record review for model me2059 lot number 20047165 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 was unable to be determined because the failure was unable to be replicated.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of flow issues - fluid blockage with lot #20047165 regarding item #me2059.H3 other text : see h.10.

• Brand Name: 72-IN NON-DEHP MICROBOREE EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 11175818
• Report Number: 9616066-2021-50058
• Device Sequence Number: 14201753
• Product Code: FPA
• UDI-Device Identifier: 10885403236273
• UDI-Public: 10885403236273
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (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): 01/18/2021

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 Expiration Date: 04/30/2023
• Device Catalogue Number: ME2059
• Device Lot Number: 20047165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1