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

Model Number 21-7346-24

Device Problem Priming Problem (4040)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

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 reportable information becomes available.

Event Description

It was reported that the patient was scheduled for daily hook and unhook via peripherally inserted central catheter (picc) for ceftriaxone at 10 am.Cadd administration set was connected to pump and primed.Tubing was not connected to patient at that time.Tubing did not prime well.Tubing was still not primed at 10 milliliters (7 milliliters tubing).They stopped pump priming.They removed tube and started again with new tubing without issue.10 milliliters from bag lost when tubing was changed.Tubing lot number was not provided.There was no patient injury reported.

Manufacturer Narrative

Other, other text: h4: device manufacturing date and d4: device expiration date could not be determined d4: device serial number/lot number is unknown.H6: event problem and evaluation codes: updated.H10: no lot number was provided; therefore, device history record review could not be performed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Brand Name: CADD
• 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; 14th floor, north tower; minneapolis, MN 55442
• MDR Report Key: 15868815
• MDR Text Key: 307692121
• Report Number: 3012307300-2022-27474
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1