MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO OPTIVA IV PLASTIC HUB / RADIOPAQUE, 20G CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 5066-AI

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

Report source foreign: (b)(6).

Event Description

Information was received that a smiths medical jelco optiva iv plastic hub / radiopaque, 20g catheter, remained in the vein.It was impossible to remove.An intervention was necessary.No further adverse patient effects were reported.

• Brand Name: JELCO OPTIVA IV PLASTIC HUB / RADIOPAQUE, 20G CATHETER
• 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 55442
• Manufacturer (Section G): SMITHS MEDICAL, INTERNATIONAL INC.; 1500 eureka park; lower pemberton; ashford, TN25 4BF; UK TN25 4BF
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 9244149
• MDR Text Key: 163920652
• Report Number: 3012307300-2019-05671
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/21/2024
• Device Catalogue Number: 5066-AI
• Device Lot Number: 3759696
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention