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

Catalog Number 383083

Device Problem Material Separation (1562)

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

Event Date 03/18/2022

Event Type  malfunction  

Event Description

It was reported while using bd intima-ii closed iv catheter system the tubing was separated.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6) 2022, during routine operation, the hose was broken when the indwelling needle was put into the blood vessel, so the hose could not be put into the blood vessel normally, leading to the puncture failure.The patient was immediately replaced, and no harm was caused to the patient.

Manufacturer Narrative

In response to the event reported a device history review was conducted for lot number 1294476.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.No actual sample and picture returned,the defect status could not be confirmed.Dhr review(lot#1294476): the complaint gauge was 24g,assembly at auto line 4 in nov.2021,packaging at cfs packing machine in nov.2021, lot quantity was (b)(4).Review the in process test and outgoing test reports for this lot product, all test results met the product specifications, no abnormal for it.Review the production records and machine troubleshooting records for this lot product,no abnormality, deviation or rework activity.Review incoming inspection records of catheter, no abnormality was observed.(the catheter for production of this lot was panel material, material number: b5171aaal, batch number:1088994/1088996/1088997/1028339/1055525/1055528) relevant functional tests of the retained sample from the same batch, please refer to the attachment for test report.Penetration force test was performed, the needle tip, catheter tip and catheter drag force were all within the product specifications.Lie distance was measured and no abnormality was found.According to the experience of previous market visits, it is suggested that customers should pay attention to the control of the initial puncture angle (15-30 degrees in principle) during the puncture process, which is conducive to feeding the catheter into the venous vessels.If the initial puncture angle is too low, the skin resistance to the catheter entering the venous vessels will increase, which may lead to the catheter peelback and puncture failure.No same complaint was received from the complaint lot.Conclusion(s) no abnormal found on process.As no defective sample returned, and the use status of the nurse was unknown, the root cause of the catheter peelback when the indwelling needle was put into the blood vessel could not be confirmed.

• 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: 14115867
• MDR Text Key: 289512059
• Report Number: 3014704491-2022-00135
• 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
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383083
• Device Lot Number: 1294476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2021
• 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