MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. OPTIVA IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 5063-AI

Device Problems Break (1069); Material Fragmentation (1261); Failure to Infuse (2340); Material Split, Cut or Torn (4008)

Patient Problem Infiltration into Tissue (1931)

Event Date 01/29/2020

Event Type  Injury  

Manufacturer Narrative

Foreign report source: (b)(6).

Event Description

Information was received indicating that during placement, when the child care worker attempted an assessment, of a smiths medical optiva iv catheter it was not functioning and on removal, it broke leaving part of the catheter in the left foot of a (b)(6) old patient.Per reporter the patient was taken to an operating room and the broken piece was subsequently removed from the foot, requiring bandages during the healing process.It was also reported that due to the issue, the patient's hospitalization was increased.No additional adverse patient effects were reported.

Manufacturer Narrative

One optiva iv catheter was returned for analysis.The visual inspection of the returned sample confirmed that 9 mm of the catheter were detached and that the severed area is irregular like the tube was torn during the use.Based on the evidence, the complaint was not confirmed.However, the issue of the catheter being detached is likely caused by user interface; as due to either the needle reinsertion or the use of lancet or scissors near the catheter.

• Brand Name: OPTIVA IV 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
• MDR Report Key: 9750831
• MDR Text Key: 181129917
• Report Number: 3012307300-2020-01580
• 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: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5063-AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Date Manufacturer Received: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 3 MO