MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7106-24

Device Problem Obstruction of Flow (2423)

Patient Problem Discomfort (2330)

Event Date 03/27/2021

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical at the end of therapy of this cadd extension sets, air was noticed in the central catheter.It was reported that patient experienced discomfort.No additional adverse effects reported.

Manufacturer Narrative

Other, other text: this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No problem or issues were identified during the device history record review.Two samples were received for evaluation.The samples were received in new condition with its original closed packaging.During functional testing, a syringe was filled with colored water to detect any occlusion.During the test, the water did not pass-through filter.The complaint is confirmed.Continue with the analysis, tried to replicate the failure mode.Based on the tests results, it is concluded that the failure could be reproduce in two ways: when the excess of solvent is not cleaned before to assembly the tube with the component or when the tube is introduced two times in the solvent dispenser (procedure is not followed).Excess of solvent was caused by not following the procedure.An alert was generated to ensure adherence to manufacturing procedure related to cleaning the excess solvent before to assembling the tube and the component.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• 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: 12202775
• MDR Text Key: 262652970
• Report Number: 3012307300-2021-07440
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Device Lot Number: 4016662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Sex: Female