MAUDE Adverse Event Report: SMITHS MEDICAL 24G SMITHS MEDICAL PROTECTIV PLUS IV; 24 GAUGE IV CATHETER

Lot Number 3441321

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2017

Event Type  Injury  

Event Description

Pt iv was being removed from r wrist, catheter tip not observed upon removal.Md suggest xray.Radiology report from xray "a non metallic radiopacity with an iv catheter like shape is present in the volar ulnar soft tissue of the distal forearm." she has been undergoing chemotherapy.She had lab work done 2 days ago and was notified this morning that she has low levels of potassium and magnesium.Pt states she feels fatigued and weak.Her oral intake had decreased.

• Brand Name: 24G SMITHS MEDICAL PROTECTIV PLUS IV
• Type of Device: 24 GAUGE IV CATHETER
• Manufacturer (Section D): SMITHS MEDICAL; dublin OH 43017
• MDR Report Key: 6913956
• MDR Text Key: 88252652
• Report Number: MW5072582
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/02/2017
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3441321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 68