MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC JELCO CONVENTIONAL PLUS IV CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 7060-AI

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/03/2020

Event Type  Injury  

Event Description

It was reported that upon removal of iv from the patient, the catheter was found missing.It was required surgically removed as a result.No further complications were reported in relation to this event.

• Brand Name: JELCO CONVENTIONAL PLUS IV CATHETERS
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD; 1500, eureka park; lower pemberton; ashford, kent TN25 4BF; UK TN25 4BF
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 10048986
• MDR Text Key: 190683950
• Report Number: 3012307300-2020-04009
• 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: distributor,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Catalogue Number: 7060-AI
• Device Lot Number: 3663533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR