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

Catalog Number 383403

Device Problem Insufficient Information (3190)

Patient Problem Phlebitis (2004)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone number: (b)(6).One unopened sample from from lot# 6018472 was returned for evaluation.Under microscopic examination, the catheter quality met manufacturing specifications.A device history review revealed no abnormal condition during production.Conclusion: an absolute root cause for this incident cannot be determined as the actual product in question was not returned for investigation.

Event Description

It is reported that a newborn, date of birth unspecified, "got nutrition infusion in (b)(6) and was sent home after infusion completed." before discharge, the nurse found a "suspicion phlebitis around insertion point." two days later, the parents found a "small node" near the insertion site.They took the newborn to the (b)(6), where a doctor prescribed the "external cream.".

• 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: 5936576
• MDR Text Key: 54205809
• Report Number: 3006948883-2016-00022
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K143610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: 383403
• Device Lot Number: 6018472
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention