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

Catalog Number 383083

Device Problem Fluid/Blood Leak (1250)

Patient Problem Erythema (1840)

Event Date 02/19/2024

Event Type  malfunction  

Manufacturer Narrative

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 24gax0.75in prn ec slm npvc leaked.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024, a nurse used a closed iv needle to administer anti-inflammatory medication to a patient during the course of the infusion of the medication oozing out of the needle, and the patient developed symptoms of redness and swelling of the skin at the eye of the needle.So immediately pulled out the needle, change the injection site to re-injection, and then the patient's discomfort symptoms improved.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review(lot#3290314): 1)this batch of products were assembled at intima ii auto line 2 in november 2023, and packaged at r240 package line in november 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.4)review the batch records, no material, process change.The sterilization process is normal, the bi sterility test is passed, and the eo residue test is passed, the products meet the requirement of bi sterility test before release, see the attachment pr# (b)(4) coc 2.No defective samples and photos have been received for the complaint.3.45psi leakage test is carried out on the retained sample of this batch, and no leakage is found.Please refer to (b)(4) attachment for the test report.4.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): there are no abnormalities in the manufacturing process, sterilization process and retained sample, and no similar complaints have been received from other hospitals about this batch of products.As no defective sample is received for analysis and confirmation, the root cause of the complained defects cannot be determined.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN 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: 18906052
• MDR Text Key: 337776858
• Report Number: 3002601200-2024-00086
• 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: 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: 04/05/2024

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: 3290314
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/15/2024
• 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