MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7605-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the use of the product, leakage of medical fluid from the connector was observed.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.
Additional Manufacturer Narrative
H10: device evaluation: two pictures were received and reviewed.Picture one shows an extension outside of its original packaging.Picture two shows a union between female luer and connector with a leak.One sample was returned for evaluation of the failure mode; the unit returned was received inside of a plastic bag with their original packaging open and decontaminated.The sample was tested using a syringe.Colored water was passed through the extension set to detect any leak; during testing, a leakage was found in the sample union between the connector and the extension tube.The complaint was confirmed.Based on the analysis conducted in the sample provided the issue was due to a lack of solvent.The failure condition was possibly due to the assembly process not being followed correctly.Failure was traced to manufacturing.For corrective action an awareness/customer complaint notification was performed to production personnel to explain the importance of adherence to manufacturing procedure 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 EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 7-1-1 akasaka,; minneapolis, MN 55442
• MDR Report Key: 15655091
• Report Number: 3012307300-2022-25834
• Device Sequence Number: 5965883
• Product Code: FPA
• UDI-Device Identifier: 10610586044113
• UDI-Public: 10610586044113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162219
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: Health Professional
• Device Expiration Date: 05/07/2024
• Device Model Number: 21-7605-24
• Device Catalogue Number: 21-7605-24
• Device Lot Number: 4279903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2022
• 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