MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO OPTIVA I.V. CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Catalog Number 1022-AI

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Information was received indicating that upon arrival of a package of smiths medical jelco optiva i.V.Catheter, inside was optiva yellow 24g.It was reported that the box was labeled as ordered optiva 22g.There were no reported adverse effects.

Manufacturer Narrative

H10: device evaluation results: one jelco catheter was returned for investigation in used condition.The defect was caused by an operator that wrongly packaged the wrong product inside the shipping box (human error).The reported product problem was therefore confirmed and a packaging error was established as the root cause.The manufacturing department was informed about the complaint.

Event Description

Additional information was received indicating that there was no patient injury/adverse effects in connection with the reported incident.

• Brand Name: JELCO OPTIVA I.V. CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• MDR Report Key: 10615369
• MDR Text Key: 209463200
• Report Number: 3012307300-2020-10029
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1022-AI
• Device Lot Number: 3886937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1