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

Lot Number ST2993704

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2016

Event Type  Injury  

Event Description

Piv placed in (b)(6) patient.After successful insertion, a hole was found at the hub of the catheter, rendering the device useless.

• Brand Name: PROTECTIV PLUS
• 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: 5476040
• MDR Text Key: 39530900
• Report Number: 5476040
• 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: 01/29/2016,02/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/01/2018
• Device Lot Number: ST2993704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR