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

Model Number 21-7115-24

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Visual inspection was conducted on 13 samples returned.The 13 samples were manufactured incorrectly placing tubing in the opposite sites of the y connector.Tubing with filter is observed to be bond in an incorrect site of the y connector.It can be seen a drawing diagram of the correct assembly in the ifu.The complaint is confirmed.A dhr review was conducted and the most probable root cause is lack of attention from operator.

Event Description

It was reported that the y site of the extension set is not assembled correctly (see picture attached in customer notification).Due to that condition, the device can't be used.Customer noticed the issue on 18 units.5 were withdrawn by users, 13 have been kept for investigation.No patient injury was reported.

Manufacturer Narrative

While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-08178 is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: CADD EXTENSION SETS
• Type of Device: 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: 14338284
• MDR Text Key: 291228891
• Report Number: 3012307300-2022-08178
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586034503
• UDI-Public: 10610586034503
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K000942
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7115-24
• Device Catalogue Number: 21-7115-24
• Device Lot Number: 3934895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0148-2022
• Patient Sequence Number: 1