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

Model Number	10800175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris¿ pca kit asv microbore cv leaked and when changing the tube there was a noticeable crack at the hub.The following information was provided by the initial reporter: the tubing leaks at y-hub (see pic).Usually leaks after the pacu hooks up tubing and the patient transports to psu.When the psu nurse changes the tubing there is a noticeable crack at the hub.
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 kit asv microbore cv leaked and when changing the tube there was a noticeable crack at the hub.The following information was provided by the initial reporter: the tubing leaks at y-hub (see pic).Usually leaks after the pacu hooks up tubing and the patient transports to psu.When the psu nurse changes the tubing there is a noticeable crack at the hub.
Additional Manufacturer Narrative
H6: investigation summary: a photo was received and analyzed by our quality team.The leakage reported was able to be verified but without further information like a physical sample, the root cause remains unknown.A device history record review for model: 10800175, lot number: 22055053 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07may2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.

• Brand Name: BD ALARIS¿ PCA KIT ASV MICROBORE CV
• 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: 15683155
• Report Number: 9616066-2022-01628
• Device Sequence Number: 6407372
• Product Code: FPA
• UDI-Device Identifier: 50885403234406
• UDI-Public: 50885403234406
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/16/2022

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: 05/07/2025
• Device Model Number: 10800175
• Device Catalogue Number: 10800175
• Device Lot Number: 22055053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2022
• Supplement Date Received by Manufacturer: 11/16/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 12/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• 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