MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP SS BAG 20D TEX; INTRAVASCULAR ADMINISTRATION SET

Model Number	10321213T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the as lvp ss bag 20d tex leaked when the spike disconnected from the iv fluid bag.The following information was provided by the initial reporter: "the account previously reported two bags leaking when the spikes disconnected from the iv fluid bag.".
Event or Problem Description
It was reported that the as lvp ss bag 20d tex leaked when the spike disconnected from the iv fluid bag.The following information was provided by the initial reporter: "the account previously reported two bags leaking when the spikes disconnected from the iv fluid bag.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 19125870.D.4.Medical device expiration date: 12/10/2022.H.4.Device manufacture date: 12/6/2019.H.6.Investigation: the customer reported that the icu medical bags leaked when bd spikes were disconnected, and returned two icu bags and two unopened bd sets.The investigation found that the bags leaked profusely when intentionally disconnected.Clinical was asked about the failure, and upon reading the icu bags, it was found that they are listed as "single use".This prompted a look into the connection, which found the bags are not designed to be resealable.The two returned spikes and icu bags did not leak when connected and appeared to be secure.There was no observed failure of the bd spike or tubing set.The issue may be the icu bag being single use and not being designed to reseal at the spike connection.A device history record review for model 10321213t lot number 19125870 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause cannot be determined without an official failure.H3 other text : see h.10.

• Brand Name: AS LVP SS BAG 20D TEX
• 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: 11853172
• Report Number: 9616066-2021-51061
• Device Sequence Number: 11766401
• Product Code: FPA
• UDI-Device Identifier: 50885403228979
• UDI-Public: 50885403228979
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• 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): 06/04/2021

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: 12/10/2022
• Device Model Number: 10321213T
• Device Catalogue Number: 10321213T
• Device Lot Number: 19125870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2021
• Initial Date Received by Manufacturer: 04/21/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1