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

Catalog Number 383005

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Inflammation (1932); Pain (1994)

Event Date 03/28/2023

Event Type  Injury  

Manufacturer Narrative

H.3.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 bd intima-ii¿ closed iv catheter system caused extravasation in the patient's vein that created swelling around the insertion site.A magnesium sulfate topical wet compress was used to treat the area.The following information was provided by the initial reporter, translated from chinese: "the patient underwent coronary cta examination on the afternoon of (b)(6).At 14:10 on (b)(6) 2023, under standardized operations, an indwelling needle was given intravenously to infuse 100ml of iodixanol injection.Ten minutes later, the indwelling needle was found to be there was drug extravasation and local swelling around the needle.The staff in the ct room suggested magnesium sulfate powder wet compress, but the patient complained that he could not buy it.At 19:30, he informed that the right upper limb was swollen and painful from the wrist.Apply magnesium sulfate topical wet compress.

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 2137709.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; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.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.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system caused extravasation in the patient's vein that created swelling around the insertion site.A magnesium sulfate topical wet compress was used to treat the area.The following information was provided by the initial reporter, translated from chinese: "the patient underwent coronary cta examination on the afternoon of (b)(6).At 14:10 on (b)(6) 2023, under standardized operations, an indwelling needle was given intravenously to infuse 100ml of iodixanol injection.Ten minutes later, the indwelling needle was found to be there was drug extravasation and local swelling around the needle.The staff in the ct room suggested magnesium sulfate powder wet compress, but the patient complained that he could not buy it.At 19:30, he informed that the right upper limb was swollen and painful from the wrist.Apply magnesium sulfate topical wet compress.

• 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 ; 8448235433
• MDR Report Key: 16894561
• MDR Text Key: 314814878
• Report Number: 3014704491-2023-00176
• 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: 05/12/2023

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 Catalogue Number: 383005
• Device Lot Number: 2137709
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2022
• 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