MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7091-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Fever (1858)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: g3:canada.D4: lot number, and expiration date is unknown.H4: device manufacture date is unknown, no information has been provided to date.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported the disposable exhibited a leak at the connection where the pca line joins the primary line.Nurse noted air in line.Nurse disconnected the line from the patient to attempt to flush the air through.When flushed from the primary line the flush continued to the end of the line, but then drained back to the connection where the pca line joins and began to leak.Patient was newly febrile but stable, unknown if related.Patient was fully cultured and the defective line and ij remove.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
Other text: one sample was received for evaluation.Visual inspection revealed the sample was broken between the bonding of the asv valve and the y-site.It was observed that inside of the y-site remained part of the asv valve; they were bonded with solvent.Functional testing was performed but the reported issue could not be replicated.No root cause could be determined as no device problem was found.No lot number was provided; therefore, a history record review could not be conducted.No action was taken.D3, g1, g2 email address: (b)(6).

• Brand Name: CADD ADMINISTRATION SETS - NON FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 17514656
• Report Number: 3012307300-2023-08058
• Device Sequence Number: 20235877
• Product Code: FPA
• UDI-Device Identifier: 10610586024160
• UDI-Public: 10610586024160
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: Health Professional
• Device Catalogue Number: 21-7091-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 08/11/2023
• Supplement Report FDA Received Date: 02/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male