MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO SERIVA CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

Model Number 8355

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2023

Event Type  Injury  

Manufacturer Narrative

D4: udi number is unknown, no information has been provided to date.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.

Event Description

The reporter stated that at surgical ward when performing the patient's puncture, part of the catheter remained within the patient's access.The event required many maneuvers to be performed removal of it, avoiding further complications.The distributor of this product is cirurgica fernandes.The product was used according to the manufacturer's instructions.The event was classified as type ii-medium risk.The event occurred during patient use and it is unknown if there was anyone harmed as a result of this event.The distributor did not receive the notification from the final customer, and in this case he could not confirm if there was anyone harmed as a result of this event.

Manufacturer Narrative

H6.Investigation codes: updated.Investigation summary: no product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.

• Brand Name: JELCO SERIVA CATHETER
• 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: 18703714
• MDR Text Key: 335364584
• Report Number: 1219611-2024-00002
• Device Sequence Number: 1
• Product Code: FOZ
• 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: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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 Model Number: 8355
• Device Catalogue Number: 8355BR
• Device Lot Number: 3158721E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/05/2024
• Supplement Dates FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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