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

Catalog Number 8355

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/29/2022

Event Type  Injury  

Event Description

It was reported that the patient canalized with jelco seriva on left hand, a piece of plastic material was stuck between the vein and the skin.Foreign material was removed.

Manufacturer Narrative

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.Pma/510k is unknown; item not sold in the united states and therefore has no 510k.However, the item is similar to other devices on the us market.

Manufacturer Narrative

H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: JELCO CONVENTIONAL SERIVA CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• Manufacturer (Section G): NULL; 201 west queen st.; southington CT 06489
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15563809
• MDR Text Key: 301364671
• Report Number: 3012307300-2022-22585
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2023
• Device Catalogue Number: 8355
• Device Lot Number: 3170618F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female