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 Problems Erythema (1840); Swelling (2091); Reaction, Injection Site (2442)

Event Date 11/12/2018

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 during use of the bd intima-ii¿ closed iv catheter system after the patient had the bd intima-ii¿ closed iv catheter system in their left forearm superficial vein the skin at the tube was red and slightly swollen.The bd intima-ii¿ closed iv catheter system was immediately removed and the patient was given magnesium sulfate injection along with cold and wet compress.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: the patient was placed with a closed venous indwelling needle at the left forearm superficial vein.After more than ten minutes, the skin at the tube was red and slightly swollen.Immediately stop using the indwelling needle and give the patient a magnesium sulfate injection cold and wet compress.

Event Description

It was reported that during use of the bd intima-ii¿ closed iv catheter system after the patient had the bd intima-ii¿ closed iv catheter system in their left forearm superficial vein the skin at the tube was red and slightly swollen.The bd intima-ii¿ closed iv catheter system was immediately removed and the patient was given magnesium sulfate injection along with cold and wet compress.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the patient was placed with a closed venous indwelling needle at the left forearm superficial vein.After more than ten minutes, the skin at the tube was red and slightly swollen.Immediately stop using the indwelling needle and give the patient a magnesium sulfate injection cold and wet compress.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8017216.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.

• 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
• MDR Report Key: 8544740
• MDR Text Key: 142920665
• Report Number: 3006948883-2019-00289
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830336
• UDI-Public: 382903830336
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: 383033
• Device Lot Number: 8017216
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention