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

Catalog Number 383033

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Discomfort (2330)

Event Date 03/22/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.E1.Address information was not provided, therefore, xx was used as a place holder.

Event Description

It was reported that bd intima-ii y 24gax0.75in prn/ec slm needle disengagement was difficult.The following information was provided by the initial reporter, translated from chinese to english: "on (b)(6) 2022, a patient was given an indwelling needle for intravenous infusion, and after entering subcutaneous retraction for the retraction operation, it was found that it was difficult to retract the core and bring out the indwelling needle tube along with it, the patient was calmed down, and the indwelling needle operation was redone by replacing the indwelling needle with a new, closed iv indwelling needle.

Manufacturer Narrative

1.Dhr/bhr review(lot#2249816): 1) this batch of products were assembled at intima ii auto line 2 in september 2022, and packaged at r240 package line in september 2022.Work order quantity was 198,000 ea.2) review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3) review the production records with no nonconformance, deviation or rework activities.2.No defective samples and photos have been received for the complaint.3.The retained sample of this lot is taken for needle removal force test, and the test result is within the product specifications, please refer to the attachment pr#9404960-1 for test report.4.The ifu of the product indicates that before puncture, hold the paddle hub and y-adapter, rotate the paddle hub to release the catheter tip adhesion, please refer to the attachment pr#9404960-2 for the view.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained sample, and no similar complaints have been received from other hospitals regarding this batch of products.Since the defect of the complained sample cannot be identified and the usage is unknown, the root cause of the difficulty in removing the needle cannot be determined , and the plant will continue to focus on such defects.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• Type of Device: INTRAVASCULAR 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18446576
• MDR Text Key: 332143574
• Report Number: 3014704491-2023-00879
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830336
• UDI-Public: (01)00382903830336
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

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 Catalogue Number: 383033
• Device Lot Number: 2249816
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/29/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1