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 08/04/2021

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 1076867.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 24g, assembly at auto line 2 in apr.2021,packaging at r240 packing machine in apr.2021, lot quantity is 186k.Reviewed the in process test and outgoing test report for this lot product, all test results met the product specifications, no abnormality found.Reviewed the production record and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities discovered.No actual sample returned.The defect status could not be confirmed.The defect is suspected to be a crack in the y- adapter.In manufacture, due to occasional fluctuation of equipment during operation, the y- adapter may cause cracking, the y- adapter crack mainly focused on adapter swaging process of zone 1, the flow chart of zone 1.Actually there is an internal improvement project for this defect.1) it was to optimize y- adapter molding cavity.S17 successfully executed by march 2019, s12 successfully executed by nov.2019.2) narrow the control limit range for swaging depth.3) according to the inspection od data of metal wedge and cracking data of mold cavity, choose matching material for metal wedge with y- adapter cavity number.Leakage test performed on the 2 retained samples, all passed.At the same time, the y- adapter of the retained sample was checked, and no abnormality was found.No similar complaint was received from this complaint lot.No abnormality found on process, as no defective sample returned, the defect is suspected to be a crack in the y- adapter ,but cannot be confirmed.The plant continues to monitor for this defect.

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 patient was admitted to hospital due to urinary tract infection, and the patient was given infusion treatment according to the doctor's advice.After the infusion of the indwelling needle, the patient's family found that the connection between the indwelling needle and the catheter tube leaked, so the indwelling needle was removed and re-punctured, and the second puncture increased the patient's pain.

• 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: 12428318
• MDR Text Key: 280705755
• Report Number: 3014704491-2021-00122
• 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: 08/16/2021

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: 04/21/2024
• Device Catalogue Number: 383033
• Device Lot Number: 1076867
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 09/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2021
• 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