MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383033

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

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 11/27/2022

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.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 after the bd intima-ii¿ closed iv catheter system was placed, the patient developed redness and swelling at the insertion site the following morning.Jinhuang powder was applied locally as a result.The following information was provided by the initial reporter, translated from chinese: "he was admitted to the hospital for 3 days due to chest tightness and breathlessness accompanied by fever, cough and sputum.On (b)(6) 2022, he was admitted to the internal medicine department.After admission, anti-infection symptomatic and supportive treatment was given, and an indwelling needle was placed for infusion.During the morning shift on (b)(6(, the patient complained of pain and discomfort in the arm where the injection was given.Check the local area immediately and find that the local skin is redness and swollen.That is, the indwelling needle was excluded, and jinhuang powder was applied locally.

Event Description

It was reported that after the bd intima-ii¿ closed iv catheter system was placed, the patient developed redness and swelling at the insertion site the following morning.Jinhuang powder was applied locally as a result.The following information was provided by the initial reporter, translated from chinese: "he was admitted to the hospital for 3 days due to chest tightness and breathlessness accompanied by fever, cough and sputum.On november 27, 2022, he was admitted to the internal medicine department.After admission, anti-infection symptomatic and supportive treatment was given, and an indwelling needle was placed for infusion.During the morning shift on (b)(6) the patient complained of pain and discomfort in the arm where the injection was given.Check the local area immediately and find that the local skin is redness and swollen.That is, the indwelling needle was excluded, and jinhuang powder was applied locally.

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 2188026.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.H3 other text : see h10.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16103281
• MDR Text Key: 306713914
• Report Number: 3014704491-2022-00724
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 383033
• Device Lot Number: 2188026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male