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

Catalog Number 383423

Device Problems Break (1069); Detachment Of Device Component (1104); Component Missing (2306)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/17/2016

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

It was reported that on (b)(6) 2016 at 9:30 am, a bd intima-ii¿ closed iv catheter system was placed in a patient's left hand for an infusion.On (b)(6) 2016 at 5:00 pm, the patient's parents notified a nurse that there was bleeding at the iv insertion site.When the nurse arrived the catheter was out of the patient's vein and approximately 15 mm was broken off and missing.The broken catheter was not found in the patient's room and the nurse reported the incident to the hospital at 10:00 pm.The patient then received full body x-rays and a cardiac color ultrasound.The broken catheter was not visualized within the patient.No further information has been provided about this incident.

Manufacturer Narrative

Results: a sample was not returned for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5295044.A manufacturing review also revealed no related issues during production.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Additionally, after communication with the customer it was reported that there was no abnormality during the insertion or flushing of the catheter, there was no abnormality found before the catheter broke, and per the incident description the catheter was torn by the patient during infusion.Therefore, our quality engineer states that the complaint is not related to manufacturing.

• 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: 5901018
• MDR Text Key: 52947784
• Report Number: 3006948883-2016-00023
• 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: 09/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 383423
• Device Lot Number: 5295044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2015
• 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: 22 MO