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

Catalog Number	82113
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the bd alaris¿ add-on burette set came apart when removing it from the packaging.The following information was provided by the initial reporter: "something about the end caps are loose.Clinical reported "it dis-assembled itself when taking it out of the package"".
Event or Problem Description
It was reported that the bd alaris¿ add-on burette set came apart when removing it from the packaging.The following information was provided by the initial reporter: "something about the end caps are loose.Clinical reported "it dis-assembled itself when taking it out of the package".
Additional Manufacturer Narrative
H6: investigation summary: twenty two samples were received for quality investigation.The customer complaint of loose component was verified by inspection.Evaluation of the samples received showed that 2 of the 22 samples had a complete lack of solvent at the bottom and top connection of the burette.Visual inspection of the joint areas do not indicate any solvent was applied to the components, and therefore allowing them to disassembled very easily.The remaining 20 samples showed significant amounts of solvent at the union of the burette to the upper and lower fittings of the assembly.There were no further issues located during the evaluation of the samples.A device history record review for model 82113 lot number 21119767 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 18nov2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure reported in this complaint is that there was insufficient solvent the union between the upper and lower fittings to the burette tube.H3 other text : see h10.

• Brand Name: BD ALARIS¿ ADD-ON BURETTE 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: 15433575
• Report Number: 9616066-2022-01349
• Device Sequence Number: 14953921
• Product Code: FPA
• UDI-Device Identifier: 07613203009614
• UDI-Public: 07613203009614
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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 Expiration Date: 11/18/2024
• Device Catalogue Number: 82113
• Device Lot Number: 21119767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 09/15/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• 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