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

Catalog Number 383083

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 10/09/2020

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.(b)(4).

Event Description

It was reported that 5 bd intima-ii¿ closed iv catheter systems experienced leakage during use.The product defect resulted in drug extravasation into the patient's surrounding tissues.The patient received medical intervention/treatment as a result.No information regarding the patient's final outcome are currently available.The following information was provided by the initial reporter: the needle hole at insertion site after the withdrawal of the needle was large, and the drugs were extravasated.Two needles were kept in the same batch, and the five affected hospitals had been treated additional information received as follows: the patient¿s hand phlebitis was after needle extraction, which had nothing to do with the quality of the needle.In the ankle patient, redness was found at the puncture site on 7th, which was estimated to be caused by the drug solution permeating to the surrounding tissues, and vb6 was injected.It was slightly acidic and belonged to irritant drugs.

Manufacturer Narrative

Investigation summary a device history review was conducted for lot number 9262090.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.Based on the provided photographs of the insertion sight our engineers believe that the leakage occurred as a result of localized inflammation.This lot was treated and received a certificate of conformance for sterility; additional causes for the observed inflammation can occur independent of the manufacturing process.

Event Description

It was reported that 5 bd intima-ii¿ closed iv catheter systems experienced leakage during use.The product defect resulted in drug extravasation into the patient's surrounding tissues.The patient received medical intervention/treatment as a result.No information regarding the patient's final outcome are currently available.The following information was provided by the initial reporter: the needle hole at insertion site after the withdrawal of the needle was large, and the drugs were extravasated.Two needles were kept in the same batch, and the five affected hospitals had been treated additional information received as follows: 1.The patient¿s hand phlebitis was after needle extraction, which had nothing to do with the quality of the needle 2.In the ankle patient, redness was found at the puncture site on 7th, which was estimated to be caused by the drug solution permeating to the surrounding tissues, and vb6 was injected.It was slightly acidic and belonged to irritant drugs.

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10774985
• MDR Text Key: 214332038
• Report Number: 3006948883-2020-00673
• 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: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/26/2022
• Device Catalogue Number: 383083
• Device Lot Number: 9262090
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention