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

Catalog Number 383028

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

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

Event Date 08/30/2023

Event Type  malfunction  

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.

Event Description

It was reported that bd intima-ii 24gax0.75in prn slm npvc had foreign matter on the needle.The following information was provided by the initial reporter, translated from chinese to english: prepared patient's supplies prior to establishing iv access and found stains on the surface of the indwelling needle, which were immediately replaced.

Event Description

Customer confirmed the foreign matter was located on the outside of the packaging unit.

Manufacturer Narrative

1.Dhr/bhr review (lot#: 2353975): 1) this batch of products were assembled at intima ii auto line 2 in january 2023, and packaged at r240 package line in january 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.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 ben received from other hospitals about this batch of products.As the status and composition of the stains on the surface 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.

• 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: 18704704
• MDR Text Key: 336446987
• Report Number: 3002601200-2024-00035
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830282
• UDI-Public: (01)00382903830282
• 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: 03/18/2024

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: 383028
• Device Lot Number: 2353975
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1