MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383062

Device Problem Break (1069)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Address information was not provided, therefore, xx was used as a place holder.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii y 20gax1.16in prn ec slm npvc had a broken connection between the tubing and adaptor.The following information was provided by the initial reporter, translated from chinese to english: at 10:15 on (b)(6) 2024, the patient underwent an enhanced ct scan.When the contrast agent was injected through a high-pressure syringe at a speed of 2.7ml/s, the connection between the indwelling needle tube and the needle handle broke, causing the examination to fail.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review(lot#3325167): 1)this batch of products were assembled at intima ii auto line 4 in december 2023, and packaged at r240 package line in december 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.No actual samples and photos have been received for the complaint.3.Sku#383062 is a product with y connection site, which has never been declared to be used for high-pressure injection.4.Functional test (45psi leakage test) is conducted on the retained sample of the complained batch, no leakage is found, and no abnormality is found on the sample.Please refer to the attached test report.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.As this product (sku 383062) has never been declared to be used for high-pressure injection, the root cause of the complained defect may be related to the wrong use of the product.H3 other text : see narrative.

• Brand Name: BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC
• 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: 18866925
• MDR Text Key: 337306781
• Report Number: 3002601200-2024-00075
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830626
• UDI-Public: (01)00382903830626
• 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: 04/29/2024

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: 383062
• Device Lot Number: 3325167
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 04/29/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1