MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE TBG W/4 FEMALE LL; INTRAVASCULAR ADMINISTRATION SET

Model Number	10015817
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4) investigation summary: no product or photo was returned by the customer.The customer complaint of leakage at the quad fuse connection 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 10015817 because a lot number was not provided by the customer.Investigation conclusion: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that ext set smallbore tbg w/4 female ll leaked.The following information was provided by the initial reporter: material #: 10015817.Batch/ lot #: unknown.It was reported that the tubing was leaking at the quad fuse connection.Verbatim: mom noted wetness on her pants as child was out of bed and broviac lines were drapped over mom leg.Nicardipine line appeared leaking at quad fuse connection slightly.Sterile gauze wrap placed and secured with gtts ordered to replace all lines.Blood pressure medication titrated throughout the shift.Monitoring closely.Nurse approximated one to one and one half mls of fluid on gauze prior to new line change.

• Brand Name: EXT SET SMALLBORE TBG W/4 FEMALE LL
• 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: 11061174
• Report Number: 9616066-2020-20631
• Device Sequence Number: 2652412
• Product Code: FPA
• UDI-Device Identifier: 50885403234055
• UDI-Public: 50885403234055
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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
• Report Date (Section B): 12/09/2020

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 Model Number: 10015817
• Device Catalogue Number: 10015817
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 12/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1