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

Catalog Number 383028

Device Problems Loose or Intermittent Connection (1371); Dull, Blunt (2407)

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

Event Date 07/04/2023

Event Type  malfunction  

Event Description

It was reported that bd intima-ii 24gax0.75in prn slm needle was loose.The following information was provided by the initial reporter; on july 4, 2023, the nurse in charge found that the indwelling needle was loose when performing infusion for the patient, making it impossible to perform normal infusion treatment.She immediately replaced the indwelling needle with a new one for infusion.

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.

• Brand Name: BD INTIMA-II 24GAX0.75IN PRN SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18167406
• MDR Text Key: 328514642
• Report Number: 3014704491-2023-00745
• 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,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383028
• Device Lot Number: 3108378
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1