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	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.(b)(4).Investigation summary: customer reported the quad-fuse was leaking, and returned the affected sample.Two large cracks causing a leak were found in 1 of the four quad fuse female luers, and the complaint is verified.No other failures were observed.Microscope analysis found the cracks to propagate from the edge of the luer down to the flanges.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: the root cause for the cracks cannot be determined, however, these sort of cracks are seen sometimes when the luer is over tightened with excessive force.
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 #: uknown.It was reported that the quad-fuse on the drip line was leaking.Verbatim: quad-fuse on drip line (infusing iv fluids and sedation meds) noted to be leaking.No obvious cracks noted.Line re-tightened but continued to leak.Complete sterile line change completed.

• 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: 10891326
• Report Number: 9616066-2020-20408
• Device Sequence Number: 13810439
• 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): 11/09/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1