MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC; CATHETER

Catalog Number 383062

Device Problem Free or Unrestricted Flow (2945)

Patient Problems Dyspnea (1816); Chest Tightness/Pressure (2463)

Event Date 10/30/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that intima-ii y 20gax1.16in prn ec slm npvc had air in the line.The following information was provided by the initial reporter: during the infusion, the patient complained of chest tightness, dyspnea and slight cough.After investigation of the cause of the drug, it was found that the intravenous indwelling needle was not qualified for sealing, leading to a small amount of air entering, which caused unnecessary injury to the patient.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9262029.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.See h.10.

Event Description

It was reported that intima-ii y 20gax1.16in prn ec slm npvc had air in the line.The following information was provided by the initial reporter: during the infusion, the patient complained of chest tightness, dyspnea and slight cough.After investigation of the cause of the drug, it was found that the intravenous indwelling needle was not qualified for sealing, leading to a small amount of air entering, which caused unnecessary injury to the patient.

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11008753
• MDR Text Key: 221524758
• Report Number: 3006948883-2020-00949
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/17/2022
• Device Catalogue Number: 383062
• Device Lot Number: 9262029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other