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

Model Number	7115
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.D5: operator of device is unknown.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.
Event or Problem Description
It was reported that the pca tubing cadd check value extension set had leak at the y-site.Per reporter, this issue was experienced in multiple sets from this lot number.There was unknown patient involvement and unknow patient harm/adverse event reported.
Additional Manufacturer Narrative
H2) additional information: a1-a6 updated.B5-b7 updated.H2) correction: d4 model number corrected.H2) device evaluation: h3, h6: no product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.
Event or Problem Description
Additional information was received from the site that the product fault occurred upon opening.There was no patient involvement, and no patient harm/adverse event reported.

• Brand Name: CADD EXTENSION
• 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: 19656303
• Report Number: 3012307300-2024-05727
• Device Sequence Number: 6914394
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: (01)10610586034503(17)290425(10)6005756
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: Other
• Device Model Number: 7115
• Device Catalogue Number: 21-7115-24
• Device Lot Number: 6005756
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2024
• 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