MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA II¿ IV CATHETER PRN ADAPTER; INTRAVASCULAR CATHETER

Catalog Number 383019

Device Problem Unintended Ejection (1234)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported a device history review was conducted for lot number 0168655.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.Unfortunately, a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.We check the retained sample from the complained batch and there is no abnormality.Bd will continue to monitor this issue.

Event Description

It was reported that bd intima ii¿ iv catheter prn adapter leaked.The following information was provided by the initial reporter: " the indwelling needle fell off and the puncture point was bleeding.".

• Brand Name: BD INTIMA II¿ IV CATHETER PRN ADAPTER
• 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
• MDR Report Key: 12619226
• MDR Text Key: 282268902
• Report Number: 3014704491-2021-00194
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/19/2023
• Device Catalogue Number: 383019
• Device Lot Number: 0168655
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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