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

Catalog Number 21-7343-24

Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981); Air/Gas in Device (4062)

Patient Problem Insufficient Information (4580)

Event Date 11/15/2023

Event Type  malfunction  

Manufacturer Narrative

Other text: d3, g1,2 email is: (b)(6).D4: lot, expiration date unavailable.H4: device manufacture date unavailable.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.

Event Description

It was reported that during use, the patient noticed a piece of rubber in the line when puncturing the rubber of the infusion bag.It was noted that the line was used for a week and a new bag was connected three times a day.It was also reported that the spike seemed to become bent after a few taps, and there had also been air in the line regularly after the filter towards the client.The rubber in the spike occasionally caused an occlusion alarm.No patient adverse effects were reported.

Manufacturer Narrative

No product was returned.The reported complaint could not be confirmed.No lot number was provided; therefore, a history record review could not be conducted.If the product is returned this complaint will be reopened for further investigation.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: CADD ADMINISTRATION SET - FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18332547
• MDR Text Key: 330973496
• Report Number: 3012307300-2023-11066
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517191820
• UDI-Public: 15019517191820
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21-7343-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• 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