MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PROTECTIV PLUS-W SAFETY I.V. CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 3087

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/26/2016

Event Type  malfunction  

Event Description

Upon discontinuing iv, part of the angio-catheter detached in the patient's wrist.A vascular surgeon was called in to remove the retained piece.Postoperative diagnosis: retained intravenous catheter in left cephalic vein.

• Brand Name: PROTECTIV PLUS-W SAFETY I.V. CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene, NH 03431
• MDR Report Key: 5801846
• MDR Text Key: 49755111
• Report Number: 5801846
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 3087
• Other Device ID Number: WINGED HUB, RADIOPAQUE, 20G X
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/05/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 94