MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II Y18GAX1.16IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383005

Device Problem Leak/Splash (1354)

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

Event Date 11/02/2021

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y18gax1.16in prn/ec slm leaked.The following information was provided by the initial reporter: "the nurse noticed fluid leakage from the indwelling needle tube during venipuncture exhausting.".

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation: a device history review was conducted for lot number 0231174.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that bd intima-ii y18gax1.16in prn/ec slm leaked.The following information was provided by the initial reporter: "the nurse noticed fluid leakage from the indwelling needle tube during venipuncture exhausting".

• Brand Name: BD INTIMA-II Y18GAX1.16IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12929147
• MDR Text Key: 287588787
• Report Number: 3014704491-2021-00322
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/26/2023
• Device Catalogue Number: 383005
• Device Lot Number: 0231174
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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