MAUDE Adverse Event Report: PCA SET Y CONN CHECK VLV 90 INCH; INTRAVASCULAR ADMINISTRATION SET

Model Number	30873
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).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 pca set y conn check vlv 90 inch experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: material #: 30873 batch/ lot #: 20077668.One staff report of a missing luer lock and tubing connector above the back check valve.The white plastic fitting above the back check valve that connects to the tube section to the luer connector was broken off above the back check valve.The broken off section was not inside the packaging.Defect was discovered prior to use.
Event or Problem Description
It was reported that the pca set y conn check vlv 90 inch experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: material #: 30873 batch/ lot #: 20077668.One staff report of a missing luer lock and tubing connector above the back check valve.The white plastic fitting above the back check valve that connects to the tube section to the luer connector was broken off above the back check valve.The broken off section was not inside the packaging.Defect was discovered prior to use.
Additional Manufacturer Narrative
H.6.Investigation: a complaint of a broken back check valve was received from the customer.Two samples were returned for investigation.On one sample no defects were noticed during visual inspection, priming, or infusion.On the second sample the back check valve was found broken.The connecting tubing had broken off.The customer complaint was confirmed.A device history record review for model 30873 lot number 20077668 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.An investigation was performed by the supplier.The investigation concluded that the defect seen could not be caused by the supplier manufacturing process.The root cause for this defect is most likely mishandling during transportation from bd to the customer.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of component damage with lot #20077668 regarding item 30873.H3 other text : see h.10.

• Brand Name: PCA SET Y CONN CHECK VLV 90 INCH
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12005950
• Report Number: 9616066-2021-51317
• Device Sequence Number: 19043708
• Product Code: FPA
• UDI-Device Identifier: 50885403273948
• UDI-Public: 50885403273948
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 09/13/2021

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: 07/31/2023
• Device Model Number: 30873
• Device Catalogue Number: 30873
• Device Lot Number: 20077668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2021
• Initial Date Received by Manufacturer: 05/18/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 09/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2020
• 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