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

Catalog Number 383028

Device Problem Material Deformation (2976)

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

Event Date 01/19/2024

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 the herapin cap was damaged from a bd intima-ii 24gax0.75in prn slm npvc.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024, the heparin cap was wiped with an alcohol swab prior to preparing for an infusion, and just after wiping it, the inside of the heparin cap was found to be flared out and structurally altered, and upon closer inspection, the perimeter of the flat surface of the heparin cap had been torn and there were two or three small holes in the heparin cap, and the heparin cap was no longer airtight, and it was being replaced with an airtight iv needle to be used.

• 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 (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: 18705132
• MDR Text Key: 335442082
• Report Number: 3002601200-2024-00039
• Device Sequence Number: 1
• Product Code: FOZ
• 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
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383028
• Device Lot Number: 3234081
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1