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

Catalog Number 21-7365-24

Device Problems Obstruction of Flow (2423); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2023

Event Type  malfunction  

Event Description

It was reported that the device tubing developed an airlock and medication could not be run through the tubing.It was stated that using a pump did not help as it still would not run.It is unknown if there was patient involvement, no adverse patient effects were reported.

Manufacturer Narrative

H3: device not received by manufacturer.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 information becomes available.

Manufacturer Narrative

No product was returned.The reported complaint could not be confirmed.If the product is returned this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.

• Brand Name: CADD ADMINISTRATION SET
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18339524
• MDR Text Key: 331053417
• Report Number: 9617604-2023-00017
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 35019517191701
• UDI-Public: 35019517191701
• 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: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

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: 21-7365-24
• Device Lot Number: 4318777
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/26/2022
• 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