MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383028

Device Problem Material Separation (1562)

Patient Problem Abrasion (1689)

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd intima-ii closed iv catheter system the catheter broke off inside the patient's body.The following information was provided by the initial reporter: in the department of neurology, the catheter tube was broken in the patient's body, and the part of the broken catheter tube hadn't been found yet.The needle was indwelled on april 26, and on april 28, the nurse found that the patient had taken it out, and informed the nurse to check it and found that the catheter was missing.Then she took the catheter tube to take an x-ray, but the catheter tube was not found.The nurse reported that the elderly patient would have restlessness, and the patient had no other discomfort at present.

Event Description

It was reported while using bd intima-ii closed iv catheter system the catheter broke off inside the patient's body.The following information was provided by the initial reporter: in the department of neurology, the catheter tube was broken in the patient's body, and the part of the broken catheter tube hadn't been found yet.The needle was indwelled on (b)(6), the nurse found that the patient had taken it out, and informed the nurse to check it and found that the catheter was missing.Then she took the catheter tube to take an x-ray, but the catheter tube was not found.The nurse reported that the elderly patient would have restlessness, and the patient had no other discomfort at present.

Manufacturer Narrative

H.6.In response to the event reported by your facility a device history review was conducted for lot number 1320193.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, the affected sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14496859
• MDR Text Key: 292610824
• Report Number: 3014704491-2022-00199
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383028
• Device Lot Number: 1320193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/25/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2021
• 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