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

Catalog Number 383033

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported by the facility a device history review was conducted for lot number 0063932.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.A 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.Bd will continue to monitor this issue.Investigation conclusion: dhr review: the complaint gauge is 24g,assembly at auto line 3 in apr.2020,packaging at cfs packing machine in apr.2020, lot quantity is 136k.Reviewed the in-process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormality for it.Reviewed the production records and machine troubleshooting records for this lot product.No abnormality, deviation or rework activities found.No actual sample and picture returned, the exact leakage point of the indwelling needle junction cannot be confirmed.Leakage test the 2 retained samples, all passed.No same complaint was received from the complaint lot.No abnormality found on process, as no defective sample returned.Further analysis could not be done.The root cause of the leakage of the indwelling needle junction could not be determined.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced leakage.The following information was provided by the initial reporter: the indwelling needle was replaced immediately when the leakage was found at the joint while giving intravenous fluids to the patient.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR 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: 12393136
• MDR Text Key: 268993116
• Report Number: 3014704491-2021-00113
• 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: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/10/2023
• Device Catalogue Number: 383033
• Device Lot Number: 0063932
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2020
• 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