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

Catalog Number	42511E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E4.The initial reporter also notified the fda on 27 jul, 2023.Medwatch report # mw5120451.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris smartsite gravity set separated and then leakage occurred.The following information was provided by the initial reporter with the verbatim: a patient was taken to the or (operating room) for induction of general anesthesia, when pushing medications the iv line broke off in two parts and medications and iv fluids spilled to the floor.A second iv (intravenous) tubing was flushed and hooked to the pt (patient).New induction medications administered and the pt.Was successfully intubated.Surgery proceeded uneventfully.This is the second incident in a week with similar iv tubing.
Additional Manufacturer Narrative
Multiple photos were received as samples for the customer's complaint of separation.The photos clearly show a separation in the 42511e device at the stopcock where tubing is to be inserted.The photos verify the complaint but without further information like a physical sample for investigation - the root cause remains unknown.The possible root cause of improper solvent application at the manufacturing plant was confirmed.The other device mentioned in complaint was purely concomitant and not involved in this failure.A quality alert was issued by the manufacturing site to correct solvent application and avoid separations of this nature.A device history record review for model 42511e lot number 23059325 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 22may2023.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
No further information.

• Brand Name: BD ALARIS SMARTSITE GRAVITY 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17731358
• Report Number: 9616066-2023-01875
• Device Sequence Number: 6164526
• Product Code: FPA
• UDI-Device Identifier: 50885403235410
• UDI-Public: (01)50885403235410
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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: Health Professional
• Device Catalogue Number: 42511E
• Device Lot Number: UNKNOWN
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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