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

Model Number	21-7115-24
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A dhr review was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.
Event or Problem Description
It was reported that "nurses came to me after 4 different patients had pca tubing that was leaking.After trouble shooting, it appeared that all the tubing seemed to be leaking in the same spot, at the y connector." no patient injury was reported.
Additional Manufacturer Narrative
Other, other text: b5: additional information received via email: customer confirmed he's reporting 2 affected items.Patient information is not known.The leaking was identified early after initiation so no adverse outcome.Slight delay while changing tubing.H6: event problem and evaluation codes: updates not required.
Additional Manufacturer Narrative
This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product was returned.We are unable to confirm the reported complaint.If the product is returned, will reopen this complaint for further investigation.

• 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; minneapolis, MN 55442
• MDR Report Key: 15154388
• Report Number: 3012307300-2022-14443
• Device Sequence Number: 12070783
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: 10610586034503
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/05/2023

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 Model Number: 21-7115-24
• Device Catalogue Number: 21-7115-24
• Device Lot Number: 4226682
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/31/2022
• 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: 03/18/2022
• Supplement Date Received by Manufacturer: 07/28/2022; 02/03/2023
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/15/2022; 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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