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

Catalog Number 383033

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Skin Inflammation (2443)

Event Date 09/08/2020

Event Type  malfunction  

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 the bd intima-ii¿ closed iv catheter system experienced catheter damage/deformation and catheter splitting/fraying during use.The following information was provided by the initial reporter: the patient was admitted to hospital on september 8 for treatment of bronchopneumonia by intravenous infusion.In wresting needle was used to facilitate fluid input and relieve the pain of daily injection.Half an hour after insertion, the infusion site of the child was swollen, painful and crying.The plastic indwelling part of the split was found when the indwelling needle was pulled out.

Event Description

It was reported that the bd intima-ii¿ closed iv catheter system experienced catheter damage/deformation and catheter splitting/fraying during use.The following information was provided by the initial reporter: the patient was admitted to hospital on september 8 for treatment of bronchopneumonia by intravenous infusion.Indwresting needle was used to facilitate fluid input and relieve the pain of daily injection.Half an hour after insertion, the infusion site of the child was swollen, painful and crying.The plastic indwelling part of the split was found when the indwelling needle was pulled out.

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 9170843.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.See h.10.

• 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: 10774967
• MDR Text Key: 219889188
• Report Number: 3006948883-2020-00672
• 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: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/27/2022
• Device Catalogue Number: 383033
• Device Lot Number: 9170843
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/10/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1