MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	10839681
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d.4.Medical device lot #: 21109122 d.4.Medical device expiration date: 25-oct-2024 h.4.Device manufacture date: 25-oct-2021 d.4.Medical device lot #: 21099260 d.4.Medical device expiration date: 28-sep-2024 h.4.Device manufacture date: 02-sep-2021.
Event or Problem Description
It was reported that the bd alaris extension set experienced leakage.The following information was provided by the initial reporter: (extension set leaking refer pr 7930267).Event 1: leaking from tri port ext set w/ll dehp free, lot number: 21109122 event 2: leaking from tri port ext set w/ll dehp free, lot number: 21099260.
Event or Problem Description
It was reported that the bd alaris extension set experienced leakage.The following information was provided by the initial reporter: (extension set leaking refer pr (b)(4)).Event 1: leaking from tri port ext set w/ll dehp free, lot number: 21109122.Event 2: leaking from tri port ext set w/ll dehp free, lot number: 21099260.
Additional Manufacturer Narrative
H6: investigation summary: the customer reported the extension set was leaking, and returned one photo of the incident.The photo verifies the separation at the outlet tubing to trifuse hub.The root cause of the incident could not be determined without the sample for investigation.Device history record review for model 10839681 lot numbers 21099260 and 21109122 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.

• Brand Name: BD ALARIS EXTENSION 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17121122
• Report Number: 9616066-2023-01165
• Device Sequence Number: 15106150
• Product Code: FPA
• UDI-Device Identifier: 50885403234536
• UDI-Public: (01)50885403234536
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 07/13/2023

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: 10839681
• Device Catalogue Number: 10839681
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 08/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown