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

Catalog Number 383078

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

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii 24gax0.75in prn slm npvc had foreign matter.The following information was provided by the initial reporter, translated from chinese to english: (b)(6) 2024 09:35 use of an iv indwelling needle to treat a sick child with iv fluids and to relieve the pain of repeated punctures.Preparing to use the indwelling needle to perform a puncture while checking the supplies, a small black spot was found on the inner wall of the indwelling needle.The needle was immediately replaced with a new one.Because of the discovery and timely treatment did not cause substantial harm to the child.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

1.Dhr/bhr review(lot#3108474): 1)this batch of products were assembled at intima ii auto line 2 in may 2023, and packaged at r240 package line in may 2023.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.Check the retained samples of this batch, no foreign matters are found.Please see attachment for the inspection report.Conclusion(s): no abnormalities are found in the process and retained samples.As the status and composition of the black spot on the inner wall of the indwelling needle cannot be confirmed, the root cause of this defect cannot be determined.The plant will continue to pay attention to and monitor such defects.

Event Description

Foreign matter was located inside of the hose.No additional information provided.

• Brand Name: BD INTIMA-II 24GAX0.75IN PRN 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: 18858683
• MDR Text Key: 337307409
• Report Number: 3002601200-2024-00072
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830787
• UDI-Public: (01)00382903830787
• 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: 04/08/2024

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: 383078
• Device Lot Number: 3108474
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1