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

Model Number	40000-07T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 2 bd alaris texium secondary sets had components separate.The following information was provided by the initial reporter: "it was reported by customer that the tubing came apart during priming.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 bd alaris texium secondary sets had components separate.The following information was provided by the initial reporter: "it was reported by customer that the tubing came apart during priming.".
Event or Problem Description
It was reported that 2 bd alaris texium secondary sets had components separate.The following information was provided by the initial reporter: "it was reported by customer that the tubing came apart during priming.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-05 h6: investigation summary the customer reported the tubing came apart during priming, and returned two used samples of material 40000-07t.The two samples were both separated below the drip chamber and the complaint is verified.The root cause is insufficient solvent applied during the assembly process.No other failure modes were observed.Manufacturing is aware of this recurring issue of drip chamber separation on the 40000-07t, and a project has been funded to address the issue.Capa 3974230 has been initiated.A device history record review for model 40000-07t lot number 20095694 was performed.The search showed that a total of 7,203 units in 1 lot number was built on 09aug2020.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 TEXIUM 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13053405
• Report Number: 9616066-2021-52627
• Device Sequence Number: 3902726
• Product Code: FPA
• UDI-Device Identifier: 50885403225626
• UDI-Public: 50885403225626
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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: 40000-07T
• Device Catalogue Number: 40000-07T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2021
• Supplement Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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