MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC; INTERVASCULAR CATHETER

Catalog Number 383083

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

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 the intima-ii y 24gax0.75in prn ec slm npvc experienced defective/damaged tubing which was noted during use.The following information was provided by the initial reporter: the extension tube was broken and leaking blood.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9050886.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 was returned and the extension tube was not inserted into the catheter adapter which is rejectable.Additionally, a review of our manufacturing facility has determined that the most likely root cause for this event is an abnormality in the automated inspection and rejection process.To address this event we have optimized station to eliminate the possibility of reoccurrence.

Event Description

It was reported that the intima-ii y 24gax0.75in prn ec slm npvc experienced defective/damaged tubing which was noted during use.The following information was provided by the initial reporter: the extension tube was broken and leaking blood.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9475252
• MDR Text Key: 180845661
• Report Number: 3006948883-2019-01095
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/30/2022
• Device Catalogue Number: 383083
• Device Lot Number: 9050886
• Date Manufacturer Received: 11/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other