MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 110 IN 15 DROP IV ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MX9968
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 110 in 15 drop iv administration set had air in the line.The following information was provided by the initial reporter: material no: mx9968 batch no: unknown.It was reported that there are multiple instances where microbubbles have been observed in the tubing, resulting in the staff being unable to flush during ablations.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported that there are multiple instances where micro-bubbles have been observed in the tubing, resulting in the staff being unable to flush during ablations.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mx9968 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text: see h10.
Event or Problem Description
It was reported that 110 in 15 drop iv administration set had air in the line.The following information was provided by the initial reporter: material no: mx9968; batch no: unknown.It was reported that there are multiple instances where microbubbles have been observed in the tubing, resulting in the staff being unable to flush during ablations.

• Brand Name: 110 IN 15 DROP IV ADMINISTRATION 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
• MDR Report Key: 11408239
• Report Number: 9616066-2021-50349
• Device Sequence Number: 16987318
• Product Code: FPA
• UDI-Device Identifier: 10885403237805
• UDI-Public: 10885403237805
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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): 03/18/2021

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 Catalogue Number: MX9968
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1