MAUDE Adverse Event Report: BECTON DICKINSON BD INTIMA; 24G PERIPHERAL VENOUS CATHETER

Catalog Number 383211

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 01/03/2013

Event Type  Injury  

Event Description

On (b)(6), 2014, the reporter stated that on (b)(6), 2013, settling on the right thigh of an intima subcutaneously to infuse a solution of glucose 2.5% and 0.45% nacl.Two hours after placement an appearance of a red plate extending over 15cm in length from the point of injection.The next day, the red plate was still present and hot to the touch.On (b)(6), 2013, they placed pyostacine.On (b)(6), 2013, hyperleucocytosis and body temperature of 37.7 to 38.2 degrees celsius: removal of the catheter.On (b)(6), 2013, the lesion was resolving.On (b)(6), 2013, the lesion resolved.On (b)(6), 2013, the antibiotic was discontinued.No further info is available.

Manufacturer Narrative

No sample was rec'd for evaluation.Unable to run complaint history check or device history review as lot number is unknown.Quality will continue to monitor on monthly trend reports.

• Brand Name: BD INTIMA
• Type of Device: 24G PERIPHERAL VENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL - INFUSION THERAPY SYSTEMS; blvd luis donaldo colosio #3100; nogales, sonora ; MX
• Manufacturer Contact: elizabeth closner, rn, bsn ; 1 becton dr.; franklin lakes, NJ 07417 ; 2105265165
• MDR Report Key: 3687553
• MDR Text Key: 4298089
• Report Number: 2243072-2014-00049
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 383211
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 93 YR