MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 22GAX1.00IN PRN/EC SLM; CATHETER

Catalog Number 383019

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 04/20/2021

Event Type  malfunction  

Manufacturer Narrative

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 intima-ii y 22gax1.00in prn/ec slm catheter was damaged.The following information was provided by the initial reporter: the patient had not eaten for three days and had poor vascular condition.The nurse made preparations for the puncture, but found it difficult to puncture the skin into the needle, so the needle was changed to continue the puncture.After careful observation of the needle in the treatment room, it was found that the tip of the catheter tube had broken and curled.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-04-30.H6: investigation summary: a device history review was conducted for lot number 0267290.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.Additionally the sample that was returned has been reviewed by our team of quality engineers.Based on their review of the damaged section of the catheter tip our engineers believe that this damage is related to resistance experienced during the puncturing process.Functional testing was performed on the retained samples to determine if the lot was performing within the limits established by product specifications.The results of these tests were unable to detect any deviations from the established limits.

Event Description

It was reported that intima-ii y 22gax1.00in prn/ec slm catheter was damaged.The following information was provided by the initial reporter: the patient had not eaten for three days and had poor vascular condition.The nurse made preparations for the puncture, but found it difficult to puncture the skin into the needle, so the needle was changed to continue the puncture.After careful observation of the needle in the treatment room, it was found that the tip of the catheter tube had broken and curled.

• Brand Name: INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11868120
• MDR Text Key: 252396294
• Report Number: 3006948883-2021-00589
• 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: 05/31/2021

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 Expiration Date: 10/25/2023
• Device Catalogue Number: 383019
• Device Lot Number: 0267290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Manufacturer Received: 04/24/2021
• Initial Date FDA Received: 05/22/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1