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

Model Number	21-7605-24
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Information was received indicating during use of the smiths medical cadd extension set, the customer noticed medical fluid was leaking from the connection part.No patient consequences were reported.No adverse effects were reported.
Additional Manufacturer Narrative
Other text: h6: event problem and evaluation codes: updated after device evaluation h10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Sample received: one (1) sample was received from p/n 21-7605-24 l/n 3965608 in used conditions, with its original open packaging.Leak test: sample was tested using a syringe with colored water.Results: during the test, leak was found between luer and tube.The complaint is confirmed.The cause of the reported problem was traced to the manufacturing process.Root cause is lack of solvent by not followed to procedure pm-417 rev.109 ?assembly, extension set? section 4.0 ?bond male luer to long tube with clamp?.Awareness notification was made to production personnel in order to explain the importance to adherence or following in the procedure pm-417 rev.109 ?assembly, extension set? section 4.0? bond male luer to long tube with clamp?, by quality engineer on 07/sep/2021.

• Brand Name: CADD
• 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: david halverson ; 6000 nathan lane north; akasaka, minato-ku, tokyo; minneapolis, MN 55442
• MDR Report Key: 12158013
• Report Number: 3012307300-2021-07157
• Device Sequence Number: 3819807
• 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): 03/03/2022

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: 04/07/2022
• Device Model Number: 21-7605-24
• Device Catalogue Number: 21-7605-24
• Device Lot Number: 3965608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• 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: 06/14/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 03/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2020
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown