MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ LVP 20D LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Model Number	11426964
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ lvp 20d low sorb experienced labeling issues.The following information was provided by the initial reporter: packaging issue, tubing is mislabeled, not the right tubing and no filter.The tubing is labeled as 10010454, but what was actually received was product # 11426964.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary: twenty-four samples of item 11426964 were submitted for quality investigation.The customer complaint of documentation error - labeled content incorrect was verified by visual inspection.Evaluation of the samples submitted shows that the label indicates that a filter was a part of the infusion set, however, when examining the samples, none of the samples has a filter assembled on the entire construction.A device history record review for model 11426964 lot number 22015543 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 19jan2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the issue seen in this complaint is misassembly caused at the manufacturing facility.H3 other text : see h10.
Event or Problem Description
It was reported that the bd alaris¿ lvp 20d low sorb experienced labeling issues.The following information was provided by the initial reporter: packaging issue, tubing is mislabeled, not the right tubing and no filter.The tubing is labeled as 10010454, but what was actually received was product # 11426964.

• Brand Name: BD ALARIS¿ LVP 20D LOW SORB
• 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: 15089728
• Report Number: 9616066-2022-00942
• Device Sequence Number: 4974719
• Product Code: FPA
• UDI-Device Identifier: 50885403232365
• UDI-Public: 50885403232365
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2022

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: 01/19/2025
• Device Model Number: 11426964
• Device Catalogue Number: 11426964
• Device Lot Number: 22015543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Supplement Date Received by Manufacturer: 08/18/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2022
• 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