MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383403

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Purulent Discharge (1812); Skin Discoloration (2074); Swelling (2091)

Event Date 02/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that on (b)(6) 2016, a bd intima-i closed iv catheter system was inserted into a patient for infusion therapy.On (b)(6) 2016, a 1cm x 1cm area of redness, stiffness, and swelling was observed and the nurse changed the iv with another bd intima-i closed iv catheter system.On (b)(6)2016, a pustule was observed at the iv insertion site.The nurse used a sterilized needle to puncture and drain the pustule and the patient's iv site was disinfected with odophor.

Manufacturer Narrative

Correction: the initial mdr reported this incident as both an adverse event and product problem.A correction is being submitted to report the incident as an adverse event only.Adverse event and/or product problem: adverse event.

Manufacturer Narrative

Although it was initially reported that a sample would be available for evaluation, a sample was not returned.A review of the device history record and the device sterility record revealed no irregularities during the manufacture of the reported lot # 5229059.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.A sample was not returned for evaluation.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5481328
• MDR Text Key: 39743913
• Report Number: 3006948883-2016-00007
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K100775
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: 383403
• Device Lot Number: 5229059
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2015
• 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: 74 YR