MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD PCA SET Y CONN CHECK VLV 90 INCH; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	30873
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s birthday was not provided, (b)(6) 2008 was used based on age of patient.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 pca set y conn check vlv 90 inch leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: 14 y/o female patient w/leaking y-site of piv.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 15-sep-2022.H6: investigation summary a used mat#30873 set was received and tested by our quality team.The leakage described at y site was immediately noticed after infusion with saline was began.A slight pull was applied to the junction and the tubing immediately came undone.A high powered digital microscope was then employed to determine possible root cause which was a lack of solvent applied during the production of this set.A device history record review for model 30873 lot number 21045496 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
Event or Problem Description
It was reported while using bd pca set y conn check vlv 90 inch leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: 14 y/o female patient w/leaking y-site of piv.

• Brand Name: BD PCA SET Y CONN CHECK VLV 90 INCH
• 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: 15506665
• Report Number: 9616066-2022-01443
• Device Sequence Number: 12734477
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: 10885403273940
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/11/2022

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: 04/09/2024
• Device Catalogue Number: 30873
• Device Lot Number: 21045496
• 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: 09/08/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2021
• 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 Age: 14 YR
• Patient Sex: Female