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

Catalog Number	21-7092-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a tubing leak.This event occurred at the patient's home.No patient harm/adverse event reported.Photos of the tube leaking were provided for complaint reference.Per reporter, upon examining the tubing, it appeared that the issue was surrounding the luer at the y site.
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 information becomes available.
Additional Manufacturer Narrative
H3/h6: the device was not returned for analysis.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.The customer provided seven photos for the evaluation.The connection of the male luer to the female luer was loose and could be manipulated.The set was leak tested.There was leakage at 1 psig from the loose connection of the check valve to the female luer of the tubing.The male luer of the check valve was found to be partially broken.When broken apart, the male luer of the check valve remained inserted into the female luer.The threads of the female luer were bent.The male luer was broken at an angle, typical of a bending force.From the seven photos above provided by the customer it was possible to identify a leak in photo #7 but in the photos 1 to 4 it is possible to see that the luer was manipulated and broken.The investigation confirmed the customer reported leaking issue.Since the sample complaint was not returned for evaluation, the failure mode cannot be attributed to the manufacturing process.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20173347
• Report Number: 3012307300-2024-08748
• Device Sequence Number: 7113021
• Product Code: FPA
• UDI-Device Identifier: 10610586024177
• UDI-Public: (01)10610586024177(17)290402(10)6005743
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K000942
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2024

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: 21-7092-24
• Device Lot Number: 6005743
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/23/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/29/2024
• 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
• Patient Sex: Unknown