MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383019

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 01/20/2024

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii y 22gax1.00in prn/ec slm needle was loose.The following information was provided by the initial reporter, translated from chinese to english: the nurse was ready to infuse fluids into the patient when she discovered that the needle was loose and couldn't be used, and immediately replaced it with a new one.When the nurse was about to give him fluids, she found that the connector of the indwelling needle was loose and could not be used, so she immediately replaced the needle with a new one, which was used normally and did not cause any injury.

Event Description

No additional information provided.

Manufacturer Narrative

Dhr/bhr review(lot#3080092): this batch of products were assembled at intima ii auto line 3 in april 2023, and packaged at cfs package line in april 2023.Work order quantity was (b)(4) ea.Review the in-process test reports and outgoing test reports, and all test results meet the product specifications.Review the production records with no nonconformance, deviation or rework activities.No defective samples and photos have been received, the specific site where the indwelling needle loosens and the defects there cannot be identified.45psi leakage test is carried out on the retained sample of this batch, and no leakage is found.Please refer to attachment for the test report.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained sample, and no similar complaints have been received from other hospitals regarding this batch of products.As the defect state of the complained sample cannot be identified, the root cause of its unusable cannot be determined.The plant will continue to follow up the complaint.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• 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: 18717016
• MDR Text Key: 336532543
• Report Number: 3002601200-2024-00040
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830190
• UDI-Public: (01)00382903830190
• 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: 383019
• Device Lot Number: 3080092
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/15/2024
• 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: 03/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1