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

Catalog Number	306201
Medical Device Problem Codes	Difficult to Insert (1316); Dull, Blunt (2407)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 1219611-2024-00001
• Device Sequence Number: 7948819
• Product Code: FOZ
• UDI-Device Identifier: 10351688071200
• UDI-Public: (01)10351688071200(17)250222(10)4261501
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2025
• Device Catalogue Number: 306201
• Device Lot Number: 4261501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown