MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTERVASCULAR CATHETER

Catalog Number 383083

Device Problem Defective Component (2292)

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

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event a device history review was conducted for lot number 8107020. 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 2 in may 2018,lot quantity is 136k. Review the in process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormal for it. Review the production record and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities. Complaint information description: the indwelling needle slide clamp could not be closed, no actual sample and picture returned, the defect status could not be confirmed. Checked the slide clamp of this lot, no abnormal found on incoming inspection. 2 pcs retained samples were taken for the slide clamp sealing test, all passed. During the test, it was found that when the tube was not centered in the slide clamp, the slide clamp could not be fully acted. No same complaint was received from the complaint lot. Conclusion(s): no defective sample returned, and no abnormal found on process, it was not clear how the nurse was using at that time, the root cause that the slide clamp could not be closed was unknown.

Event Description

It was reported that the intima-ii y 24gax0. 75in prn ec slm npvc experienced a defective/deformed tubing clamp. The following information was provided by the initial reporter: the patient used the product in the catheterization room during coronary angiography on (b)(6) 2021, and returned to the ward after surgery and found that the indwelling needle clamp could not be closed, so the indwelling needle was replaced immediately.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12081455
• MDR Text Key: 260107126
• Report Number: 3006948883-2021-00714
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/16/2021
• Device Catalogue Number: 383083
• Device Lot Number: 8107020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial