MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II; INTRAVASCULAR CATHETER

Catalog Number 383083

Device Problem Defective Component (2292)

Patient Problem Phlebitis (2004)

Event Date 03/18/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii tubing was defective/damaged.The following information was provided by the initial reporter: the department of cardiology of (b)(6) hospital found that in the past six months, the xiangma extension tube was rough in workmanship and had lines, the feel was harder than before, and the catheter was also harder than before, resulting in a significant increase in the incidence of phlebitis in patients recently.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

1.Dhr/bhr review(lot#3199727): 1) this batch of products were assembled at intima ii auto line 4 in august 2023, and packaged at cfs package line in august 2023.Work order quantity was (b)(4) 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.The customer has returned a replacement sample.1) microscopic examination of the sample: the appearance of extension tubing meets the current acceptance standards, and no abnormalities are found on the needle tip, the catheter tipping, and the catheter surface.2) penetration force test is carried out on the sample, and the test results are within the product specifications.Please see attachment (b)(4) for photos and attachment (b)(4)2 for test reports.3.About the extension tubing: 1) the appearance of the extension tubing is related to the extrusion process parameters, and the adjustment of parameters will bring certain changes to the appearance of the extension tubing.The extension tubing batches used in this batch of products are 3113565, 3177049 and 3139900.The relevant production records are reviewed, no abnormality is found, the parameter settings are within the range, and the appearance inspections are all qualified.2) in order to improve customer satisfaction, the plant is readjusting the acceptance standards for the appearance of the extension tubing, making samples for comparison, and modifying the sop document mfg-0062.3) for the feel of the extension tubing, the plant does not have this test item.4.About the catheter and the phlebitis: 1)t he catheters for bd indwelling needle products have always been supplied by the bd sandy facility.Review incoming inspection records of catheter, no abnormalities.(material number: b5171aaal, batch number: 3094808, 3083132, 3128016, 3142540) 2) quality indicators related to phlebitis are sterility of the products and penetration force of the product (including the needle tip force, catheter tip force and catheter drag force).Please see attachment (b)(4) for the product sterilization report.5.The retained samples of the batch are taken for the appearance inspection and penetration force test, and the results show that the appearances of the extension tubing meet the current acceptance standards, and the penetration force test results are within the product specifications.Please see attachment (b)(4) for the test reports.6.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained samples, and no similar complaints have been received from other hospitals regarding this batch of products.The appearance of the extension tubing of the returned sample meets the current standard, and the relevant testing of the catheter is not abnormal.In order to improve customer satisfaction, the plant is readjusting the acceptance standards for the appearance of the extension tubing, making a sample for comparison, and modifying the sop document mfg-0062.

Event Description

The department of cardiology of (b)(6) hospital found that in the past six months, the xiangma extension tube was rough in workmanship and had lines, the feel was harder than before, and the catheter was also harder than before, resulting in a significant increase in the incidence of phlebitis in patients recently.

• Brand Name: BD INTIMA-II
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19063822
• MDR Text Key: 340461778
• Report Number: 3002601200-2024-00127
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830831
• UDI-Public: (01)00382903830831
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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: 383083
• Device Lot Number: 3199727
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 05/01/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1