MAUDE Adverse Event Report: BD BD ARTERIAL CANNULA; CATHETER

Catalog Number 682245

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Pain (1994); Tissue Damage (2104); Numbness (2415)

Event Date 08/13/2013

Event Type  Injury  

Event Description

On (b)(6) 2014, the reporter stated that the patient had neurosurgical procedure on (b)(6) 2013.The patient presented with pain over right wrist at site of arterial cannula insertion.Consultant pain team documented an area of sensory loss related to the superficial branches of the radial nerve at the wrist.In (b)(6) 2013, an ultrasound demonstrated the cannula sheath to still be present in the right radial artery.On (b)(6) 2014, the cannula was surgically removed.

Manufacturer Narrative

A sample was rec'd and in the process of being evaluated.Once the evaluation is complete the information will be sent as a supplemental.Unable to run complaint history check or device history review as lot number is unknown.

• Brand Name: BD ARTERIAL CANNULA
• Type of Device: CATHETER
• Manufacturer (Section D): BD; one becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD SINGAPORE BRANCH; 30 tuas avenue 2; 6394 61; SN 639461
• Manufacturer Contact: elizabeth closner, rn, bsn ; 1 becton dr.; franklin lakes, NJ 07417 ; 2105265165
• MDR Report Key: 3594769
• MDR Text Key: 4066506
• Report Number: 2243072-2014-00009
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 682245
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• 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: 39 YR