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

Catalog Number 383033

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Chills (2191)

Event Date 08/28/2019

Event Type  Injury  

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 was involved in a serious injury in the form of medical intervention.The patient developed chills while being treated for heart failure, after which dexamethasone was administered.There is no information currently available regarding the final outcome of this incident.The following information was provided by the initial reporter: on (b)(6) 2019, the patient was treated with intima-ii of hermetic intravenous indwelling needle due to heart failure.During the use, the patient developed chills and was immediately stopped.Dexamethasone 5mg was injected intravenously and the patient was relieved after an hour.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number: 9077841.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.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 the intima-ii y 24gax0.75in prn/ec slm was involved in a serious injury in the form of medical intervention.The patient developed chills while being treated for heart failure, after which dexamethasone was administered.There is no information currently available regarding the final outcome of this incident.The following information was provided by the initial reporter: on (b)(6) 2019, the patient was treated with intima-ii of hermetic intravenous indwelling needle due to heart failure.During the use, the patient developed chills and was immediately stopped.Dexamethasone 5mg was injected intravenously and the patient was relieved after an hour.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• 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: 9180812
• MDR Text Key: 162783295
• Report Number: 3006948883-2019-00854
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/09/2022
• Device Catalogue Number: 383033
• Device Lot Number: 9077841
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other