MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7609-24

Device Problems Obstruction of Flow (2423); Failure to Align (2522)

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

Event Date 03/01/2024

Event Type  malfunction  

Event Description

It was reported that while customer was using it, a blockage alarm occurred, and customer was no longer able to use it.At that time, the yellow cover had shifted.It is unclear when the cover was removed.Correct the misalignment and use it.This occurred during use/infusion.There was patient involvement and no patient harm/adverse event reported.

Manufacturer Narrative

B3: month and year of event have been provided; day is unknown.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.

Manufacturer Narrative

One sample was received for evaluation in addition to three photos.Review of the three photos found no discrepancies.Visual and functional review of the sample found no discrepancies.The failure mode ¿occluded/blockage¿ was not confirmed.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• Brand Name: CADD CASSETTE RESERVOIRS - FLOW STOP NRFIT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19098467
• MDR Text Key: 340797692
• Report Number: 9617604-2024-00320
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162219
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 21-7609-24
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/11/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/12/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1