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 Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.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 there were cracks that caused leakage.There was no report of patient impact.The following information was provided by the initial reporter: customer reports there is a crack in valve connection, which has caused leakage.Awareness date: 07/19/23.
Event or Problem Description
It was reported while using bd pca set y conn check vlv 90 inch there were cracks that caused leakage.There was no report of patient impact.The following information was provided by the initial reporter: customer reports there is a crack in valve connection, which has caused leakage.Awareness date: 07/19/23.
Additional Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17480899
• Report Number: 9616066-2023-01674
• Device Sequence Number: 8975966
• Product Code: FPA
• UDI-Device Identifier: 10885403273940
• UDI-Public: (01)10885403273940
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/16/2023

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 Catalogue Number: 30873
• Device Lot Number: UNKNOWN
• 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: 07/19/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 08/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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