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

Catalog Number 383012

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/11/2021

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 0063904.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: the complaint gauge is 20g,assembly at auto line 1 in mar.2020,packaging at cfs packing machine in mar.2020, lot quantity is 136k.Review performed for the in process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormality found for it.Review performed on the production record and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities found.Key factors for defects complained by customers: the external force.The applicator was not fixed properly.It is recommended to hold the film tension-free when applying the dressing, align the position, pinch the periphery of the hose seat, and press the whole dressing from inside to outside.No similar complaint was received from the complaint lot.No abnormality found on process, according to the complaint information, the liquid leakage may be caused by the external pulling force and the improper fixation of the indwelling needle application, and not to the quality of the indwelling needle product.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced leakage, and the catheter backing out of the vein.The following information was provided by the initial reporter: due to the intense emotion and irritability of the patient, the indwelling syringe sleeve was pulled out by external force and withdrew from the venous lumen, resulting in fluid leakage.

• 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
• MDR Report Key: 12345279
• MDR Text Key: 267470611
• Report Number: 3014704491-2021-00086
• 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: 08/07/2021

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: 03/21/2023
• Device Catalogue Number: 383012
• Device Lot Number: 0063904
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2021
• Initial Date FDA Received: 08/19/2021
• 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