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

Model Number	11448964
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed and the franklin lakes fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.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 unspecified bd alaris¿ pump module smartsite¿ infusion set tubing separated at the pump segment.The following information was provided by the initial reporter: "there was also a pump segment separation received.".
Event or Problem Description
It was reported that the bd alaris¿ secondary set the tubing separated at the pump segment.The following information was provided by the initial reporter: "there was also a pump segment separation received.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: b5: describe event or problem: it was reported that the bd alaris¿ secondary set the tubing separated at the pump segment.The following information was provided by the initial reporter: "there was also a pump segment separation received." d1: medical device brand name: bd alaris¿ secondary set.D4: udi # (b)(4).D4: catalog #11448964.D4: medical device lot #: 22053234.D4: medical device expiration date: 19-may-2025.G.5.Pma / 510(k)#: k790582.H4: device manufacture date: 10-may-2022.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-may-2023.Investigation summary: one sample was received and tested by our quality team.The set was separated upon receipt which has verified the customer's complaint.The upper silicone portion of tubing that is inserted into pump was analyzed under a high power digital microscope and there seemed to be a deformation present in the tube.The manufacturer was contacted and the root cause has been determined to be an improper assembly most likely due to camera used to produced sets being misaligned at time of assembly.The camera has since been aligned properly and a fixture has been added to the bench to help insure the alignment of sets for proper insertion.A device history record review for model 11448964 lot number 22053234 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported that the bd alaris¿ secondary set the tubing separated at the pump segment.The following information was provided by the initial reporter: "there was also a pump segment separation received.".

• Brand Name: BD ALARIS¿ SECONDARY 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 NJ 22244
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16615077
• Report Number: 2243072-2023-00474
• Device Sequence Number: 6255226
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: (01)50885403234741
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K790582
• 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,Followup
• Report Date (Section B): 06/01/2023

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 Expiration Date: 05/19/2025
• Device Model Number: 11448964
• Device Catalogue Number: 11448964
• Device Lot Number: 22053234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 04/03/2023; 06/01/2023
• Initial Report FDA Received Date: 03/24/2023
• Supplement Report FDA Received Date: 05/11/2023; 06/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/10/2022
• 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