MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y18GAX1.16IN PRN/EC SLM; CATHETER

Catalog Number 383005

Device Problem Leak/Splash (1354)

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

Event Date 02/23/2020

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.

Event Description

It was reported that an intima-ii y18gax1.16in prn/ec slm leaked.The following information was provided by the initial reporter: "the male patient had paroxysmal chest tightness and shortness of breath for half a month.At 14:03 on (b)(6) 2020, when coronary ct was performed, the end cap of the positive pressure indwelling needle was loosen, and the iohexol contrast agent was leaked out, it was caused the patient to undergo repeated examinations and received excess radiation and the needle was immediately changed the contrast agent and re-punctured again.".

Manufacturer Narrative

Investigation summary a device history review was conducted for lot number 9077588.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.Unfortunately, a sample could not be obtained for evaluation and testing.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 an intima-ii y18gax1.16in prn/ec slm leaked.The following information was provided by the initial reporter: "the male patient had paroxysmal chest tightness and shortness of breath for half a month.At 14:03 on (b)(6) 2020, when coronary ct was performed, the end cap of the positive pressure indwelling needle was loosen, and the iohexol contrast agent was leaked out, it was caused the patient to undergo repeated examinations and received excess radiation.And the needle was immediately changed the contrast agent and re-punctured again.".

• Brand Name: INTIMA-II Y18GAX1.16IN PRN/EC SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 10060918
• MDR Text Key: 191139535
• Report Number: 3006948883-2020-00187
• 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: 06/01/2020

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: 04/24/2022
• Device Catalogue Number: 383005
• Device Lot Number: 9077588
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/15/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other