MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7336-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device iv line had separated from the luer lock end.Client reinserted the tubing back into the luer lock end and taped it, saw no further leaking.No patient injury was reported.
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Operator of device is unknown.Initial reporter also sent report to fda is unknown.
Additional Manufacturer Narrative
Other text: b5: additional information received on 03-aug-2022 via email and attached to complaint object: the incident happened during use.H6: event problem and evaluation codes: updates not required.
Additional Manufacturer Narrative
Event problem and evaluation codes: updated.Device evaluated by manufacturer: updated.H10: device evaluation: one sample was returned for investigation.The returned sample was received in used condition without original packaging.The sample was visually inspected under normal conditions of illumination to detect any condition that could cause the failure mode reported.One sample was received with the valve check detached a light mark of solvent were detected on tube tip; while the other was received with valve join to the tube.The sample that was received with the join was tested using the pressure tank and with colored water to detect any leak; during testing, a leak was detected.The complaint is confirmed.Based on the analysis conducted in the sample provided, the failure condition was possibly due to incorrect solvent dispense set up (insufficient solvent in solvent pot).The problem source was traced to manufacturing.For corrective action production personnel were notified by quality engineer as awareness for the failure mode reported by customer.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4) as a result of warning letter cms# (b)(4).

• Brand Name: CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; seventh street plaza; minneapolis, MN 55442
• MDR Report Key: 14745772
• Report Number: 3012307300-2022-12224
• Device Sequence Number: 5327224
• Product Code: FPA
• UDI-Device Identifier: 10610586027291
• UDI-Public: 10610586027291
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/30/2023

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 Expiration Date: 07/20/2025
• Device Model Number: 21-7336-24
• Device Catalogue Number: 21-7336-24
• Device Lot Number: 4025381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 02/03/2023
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 08/25/2022; 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2020
• 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 Sex: Unknown