MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA II¿ IV CATHETER 24G X 0.75; INTRAVASCULAR CATHETER

Catalog Number 383408

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that on the second day of infusion, the patient removed the suspect device from the back of the hand in the middle of the night.The nurse found the catheter broken after two hours.The patient had a ct scan of the arm but the brother catheter was not detected.

Manufacturer Narrative

Additional information added as follows: sex - female.Describe event or problem - this incident occurred in the department of neurology.The patient had suffered a stroke and was delirious.Blood was noted inside of the extension catheter after removal but the patient is not known to have an infectious disease.The patient has since been discharged from the hospital.Device evaluation: result - one actual used sample was returned for evaluation.A visual examination of the sample was performed and found the catheter was broken from the root of the catheter.This section of catheter was noted to have stretch marks.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 6134279.This device was manufactured in july 2016.Conclusion - bd was able to confirm the customer's indicated failure mode.The returned sample broken catheter cross section has a tensile deformation.According to complaint information, the patient pulled out the device.Therefore, the probable root cause of this defect is patient stretching the device.

Event Description

This incident occurred in the department of neurology.The patient had suffered a stroke and was delirious.Blood was noted inside of the extension catheter after removal but the patient is not known to have an infectious disease.The patient has since been discharged from the hospital.

• Brand Name: BD INTIMA II¿ IV CATHETER 24G X 0.75
• 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: 6228403
• MDR Text Key: 64034219
• Report Number: 3006948883-2017-00001
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 383408
• Device Lot Number: 6134279
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention