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

Catalog Number 383012

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/22/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that bd intima-ii had foreign matter the dealer reported that the following information was provided by the initial reporter: foreign matter was found in the extension tube when receiving the goods in the hospital's warehouse.The defective quantity of 1 tube was returned to the upper-level dealer (the name of the upper-level dealer was not provided), indicating that the problem had been reported to the upper-level dealer, but the dealer did not provide any information.Reply.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review(lot#3290307): 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 defective samples and photos have been received for the complaint.3.Check the retained samples of this batch, no foreign matters are found in the extension tubing.Please see attachment for the inspection report.4.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormalities are found in the process and retained samples, and no similar complaints have been received from other hospitals about this batch of products.As the status and composition of the foreign matter in the extension tubing cannot be confirmed, the root cause of this defect cannot be determined.H3 other text : see narrative.

• 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 (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19130348
• MDR Text Key: 341464130
• Report Number: 3002601200-2024-00141
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830121
• UDI-Public: (01)00382903830121
• 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
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383012
• Device Lot Number: 3290307
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1