MAUDE Adverse Event Report: SMITHS MEDICAL ASD VIAVALVE IV CATHETER; JELCO IV CATHETER

Catalog Number 3267

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Test Result (2695); Device Embedded In Tissue or Plaque (3165)

Event Date 06/29/2015

Event Type  Injury  

Event Description

The rn was in room and noticed the iv site was bloody and upon further assessment prior to removing the dressing i noticed the iv hub sticking out from under the dressing without the plastic cannula attached.An x-ray was taken and found a linear radiopaque foreign body in the dorsal soft tissues in the distal forearm.Attempts to remove it at the bedside and ir were unsuccessful.It could not be removed percutaneously.The pt will need to have it removed in the operating room.Event not abated after use stopped or dose reduced.

• Brand Name: VIAVALVE IV CATHETER
• Type of Device: JELCO IV CATHETER
• Manufacturer (Section D): SMITHS MEDICAL ASD
• MDR Report Key: 4924377
• MDR Text Key: 21130248
• Report Number: MW5044393
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/01/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Catalogue Number: 3267
• Device Lot Number: ST2948344
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 43