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

Catalog Number 383019

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

Patient Problems Cyanosis (1798); Chills (2191)

Event Date 05/22/2021

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 the patient developed chills, shortness of breath, and cyanosis while using intima-ii y 22gax1.00in prn/ec slm.The following information was provided by the initial reporter: at 9:45 am on (b)(6) 2021, the patient developed sudden chills, chills, shortness of breath, and cyanosis of the skin of the whole body while administering 0.9%ns 250ml+ vitamin c injection 2g+ potassium chloride injection 0.79g.T36.9, p133 times/min, r32 times/min, bp130/78mmhg.The infusion of reorganized drug was stopped immediately, and the infusion set was replaced.Ecg monitoring and oxygen saturation monitoring were performed, and oxygen inhalation was performed.25mg of promethazine hydrochloride injection was given intramuscular sedation, and 10mg of dexamethasone sodium phosphate injection was injected for anti-allergy.The patient's symptoms were improved after light treatment.10:10 was t38.9, and 4ml of bupleurum injection and 0.1 of compound aminobarbital were injected intramuscularly to cool the temperature.10:25 t39.0 was re-measured and vital signs were continued.12:00 t37.0¿ p88 times/min,r21 times/min, bp120/70mmhg.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8305823.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, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, 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 patient developed chills, shortness of breath, and cyanosis while using intima-ii y 22gax1.00in prn/ec slm.The following information was provided by the initial reporter: at 9:45 am on (b)(6), 2021, the patient developed sudden chills, chills, shortness of breath, and cyanosis of the skin of the whole body while administering 0.9%ns 250ml+ vitamin c injection 2g+ potassium chloride injection 0.79g.T36.9, p133 times/min, r32 times/min, bp130/78mmhg.The infusion of reorganized drug was stopped immediately, and the infusion set was replaced.Ecg monitoring and oxygen saturation monitoring were performed, and oxygen inhalation was performed.25mg of promethazine hydrochloride injection was given intramuscular sedation, and 10mg of dexamethasone sodium phosphate injection was injected for anti-allergy.The patient's symptoms were improved after light treatment.10:10 was t38.9, and 4ml of bupleurum injection and 0.1 of compound aminobarbital were injected intramuscularly to cool the temperature.10:25 t39.0 was re-measured and vital signs were continued.12:00 t37.0 p88 times/min,r21 times/min, bp120/70mmhg.

• Brand Name: INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 12072073
• MDR Text Key: 264973365
• Report Number: 3006948883-2021-00707
• 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: 07/06/2021

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?: No
• Device Operator: Other
• Device Expiration Date: 11/24/2021
• Device Catalogue Number: 383019
• Device Lot Number: 8305823
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention