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

Catalog Number 383423

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

Patient Problems Purulent Discharge (1812); Unspecified Infection (1930)

Event Date 12/27/2017

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

On the third day of infusion, it was reported that a nurse noticed an infant¿s puncture point had developed an infection with a bd intima ii¿ iv catheter.The nurse disinfected the infant¿s area of infection with iodine, treated the infant with medication.Surgical treatment was performed to pump out the purulent fluid.The infant was discharged from the hospital on (b)(6) 2018.No further updates have been reported regarding additional treatment or medical intervention.

Manufacturer Narrative

Investigation results: representative samples provided by the customer.The failure mode could not be observed in the samples provided.The batch history record was reviewed; no abnormalities were noted.The representative samples passed bi aseptic testing.Other possible factors are: repeated infusion in a vein, causing the vascular wall to suffer from hyperplasia, hypertrophy, leading to phlebitis.A puncture through the vein of the patient that went undetected could result in the formation of a hematoma that can lead to local swelling and ultimately leading to phlebitis.Disinfection procedure was not adequate leading to the infection.Phlebitis can also be caused by an improper drug-ratio during infusion.Conclusion: bd could not find evidence linking the manufacture of this device to the reported failure mode.No additional corrective action is required at this time.

• Brand Name: BD INTIMA II¿ IV CATHETER
• 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: 7213000
• MDR Text Key: 98004319
• Report Number: 3006948883-2017-00220
• 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
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 383423
• Device Lot Number: 6335465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2016
• 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): Hospitalization; Required Intervention