MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7115
Medical Device Problem Codes	Break (1069); Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: facility name "(b)(6) hospital." 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 two photos for the evaluation.Photo 1- shows a label of the product extension set p/n: 21-7115-24 l/n:4453483, the sample reported in the complaint.Photo 2- shows an extension set incomplete, is possible to see a disconnection in the y site and valve.The investigation confirmed the customer reported disconnection issue.Since the sample complaint was not returned for evaluation, the failure mode cannot be attributed to the manufacturing process.A device history review had no significant findings.
Event or Problem Description
It was reported that the tubing detached at the patient's home without the family handling it.Per reporter, this is not the first time this has happened.The ide tested 2 other tubing in stock in its service- by forcing a little, the valve broke on one of the open tubing.On the 2nd tubing, the valve cannot be misadapted.Per reporter, the problem was discovered during use with the patient.The issue of the device did not aggravate the patient's condition, but the nurse had to change the equipment.
Additional Manufacturer Narrative
D3: correction.D9: 13-nov-2024.H3: eleven photos were provided for evaluation, and two samples were returned in used condition.The returned samples were visually inspected and visual defects were found.On sample 1, the ¿y¿ tube is damaged and stuck to the male luer.On sample 2, male luer could not be detached from the ¿y¿ tube.A lot history review was performed for lot number 4453483 and no anomalies were identified.The cause of the defects is unknown.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana MN ; MX
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19931923
• Report Number: 3012307300-2024-07293
• Device Sequence Number: 2736157
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: (01)10610586034503(17)290105(10)4453483
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 7115
• Device Catalogue Number: 21-7115-24
• Device Lot Number: 4453483
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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 Age: 87 YR
• Patient Sex: Male