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

Lot Number 3323723

Device Problems Hole In Material (1293); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 04/28/2017

Event Type  malfunction  

Event Description

I attempted to place a peripheral intravenous line (piv) in the patient's right hand using a 24 3/4 inch jelco catheter.I was able to place in the vein, obtained a flash and then attempted to advance the catheter.I retracted the needle and noticed bleeding around the site of insertion of the catheter.I attempted to continue to advance the catheter and was unable to.I took the needle and catheter out and noticed there was a hole in the catheter.The defective product was not saved.

• Brand Name: PROTECTIV PLUS
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 6621665
• MDR Text Key: 76972498
• Report Number: 6621665
• 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: 05/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3323723
• Other Device ID Number: SMITHS MEDICAL PRODUCT CODE -
• 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: 05/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 YR