MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROP 16 X 1 1/4 200/CA; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Catalog Number 306201

Device Problems Difficult to Insert (1316); Dull, Blunt (2407)

Patient Problem Insufficient Information (4580)

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that the material showed a drop in quality and presented greater difficulty in puncturing veins, even easy punctures, due to the needle thread.There was patient involvement.It was stated that there was patient harm since the patient was exposed to catheter exchange, new puncture, and therapeutic delay and risk.The affected product is not available for evaluation.

Manufacturer Narrative

G5: 510k number is unknown.H3: other; device not returned to 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 reportable information becomes available.

Manufacturer Narrative

No product sample was received; therefore, visual and functional testing could not be performed.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.The reported issue could not be confirmed.Based on the available information, the reported issue could not be confirmed and no root cause could be found.No actions have been taken.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: PROP 16 X 1 1/4 200/CA
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st; southington CT 06489
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18505818
• MDR Text Key: 332868490
• Report Number: 1219611-2024-00001
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10351688071200
• UDI-Public: (01)10351688071200(17)250222(10)4261501
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306201
• Device Lot Number: 4261501
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/04/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• 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
• Patient Outcome(s): Required Intervention