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

Model Number	30873
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
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 pca administration set was cracked.The following information was provided by the initial reporter: reported issue: cracked tubing connector.
Additional Manufacturer Narrative
Investigation summary: one sample was received for quality investigation.The customer complaint of component damage was verified by visual inspection.Evaluation of the submitted sample shows that the female luer adapter connector is cracked with a portion of the connector missing.The missing portion of the female luer connector is on the body of the connector that would interact with a corresponding male luer connection.No other issues were found on the extension set.A device history record review for model 30873 lot number 21065581 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 08jun2021.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 issue seen in this complaint could not be fully determined.
Event or Problem Description
It was reported that the bd alaris pca administration set was cracked.The following information was provided by the initial reporter: reported issue: cracked tubing connector.

• Brand Name: BD ALARIS PCA ADMINISTRATION 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: 14581253
• Report Number: 9616066-2022-00676
• Device Sequence Number: 17493814
• Product Code: FPA
• UDI-Device Identifier: 50885403273948
• UDI-Public: 50885403273948
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K811885
• 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): 08/10/2022

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: 06/08/2024
• Device Model Number: 30873
• Device Catalogue Number: 30873
• Device Lot Number: 21065581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 06/02/2022
• Supplement Report FDA Received Date: 09/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• 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