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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 while using bd alaris¿ secondary set separation and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: a bd secondary kit was open and used to spike a bag of medication.The tubing broke just below the drip chamber causing the medication to spill out.A second bd secondary kit from the same lot was then opened and also broke in the same location, just below the drip chamber.Medication wasted; exposure of staff to potentially harmful medications both tubing saved for return if deemed necessary.
Event or Problem Description
It was reported while using bd alaris¿ secondary set separation and leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: a bd secondary kit was open and used to spike a bag of medication.The tubing broke just below the drip chamber causing the medication to spill out.A second bd secondary kit from the same lot was then opened and also broke in the same location, just below the drip chamber.Medication wasted; exposure of staff to potentially harmful medications both tubing saved for return if deemed necessary.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution? yes, d10: returned to manufacturer on: 07-jun-2023 h6: investigation summary the customer reported the tubing broke at the drip chamber, spilling medication.The two samples returned both verified the complaint, and had the same failure.The failure is consistent with a project at the plant to correct and prevent further failures of this type.The root cause is insufficient solvent applied during the assembly process, and the plant is working on it under the project.Device history record review for model 11448964 lot number 23019047 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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
• 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 ; 8448235433
• MDR Report Key: 17095597
• Report Number: 9616066-2023-01138
• Device Sequence Number: 13920397
• Product Code: FPA
• UDI-Device Identifier: 50885403234741
• UDI-Public: (01)50885403234741
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 06/29/2023

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: 01/05/2026
• Device Model Number: 11448964
• Device Catalogue Number: 11448964
• Device Lot Number: 23019047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 06/29/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 07/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2023
• 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